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Trial record 50 of 97 for:    calcium cation

Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis

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ClinicalTrials.gov Identifier: NCT02341417
Recruitment Status : Completed
First Posted : January 19, 2015
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Secondary Hyperparathyroidism, Chronic Kidney Disease
Intervention Drug: Cinacalcet
Enrollment 28

Recruitment Details This study was conducted at 16 centers in United States, Russian Federation, Ukraine, Belgium, Czech Republic, Greece, France, and Poland.
Pre-assignment Details This extension study enrolled participants who completed one of the parent studies 20110100 (NCT01439867) or 20130356 (NCT02138838). Results are reported by treatment received in the parent study.
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
Hide Arm/Group Description Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Period Title: Overall Study
Started 13 14 1
Completed 11 12 0
Not Completed 2 2 1
Reason Not Completed
Withdrawal by Subject             0             2             0
Decision by sponsor             2             0             0
Death             0             0             1
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet Total
Hide Arm/Group Description Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. Total of all reporting groups
Overall Number of Baseline Participants 13 14 1 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 14 participants 1 participants 28 participants
14.0
(9 to 18)
14.0
(7 to 17)
2.0
(2 to 2)
14.0
(2 to 18)
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 1 participants 28 participants
28 days to < 2 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2 to < 6 years
0
   0.0%
0
   0.0%
1
 100.0%
1
   3.6%
6 to < 12 years
4
  30.8%
6
  42.9%
0
   0.0%
10
  35.7%
12 to ≤ 18 years
9
  69.2%
8
  57.1%
0
   0.0%
17
  60.7%
[1]
Measure Description: One participants in the 20130356 SOC group was 17 years old at the time of enrollment of parent study and had turned 18 at the time of enrollment of Study 20140159.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 1 participants 28 participants
Female
8
  61.5%
10
  71.4%
0
   0.0%
18
  64.3%
Male
5
  38.5%
4
  28.6%
1
 100.0%
10
  35.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 1 participants 28 participants
Hispanic or Latino
1
   7.7%
0
   0.0%
0
   0.0%
1
   3.6%
Not Hispanic or Latino
12
  92.3%
14
 100.0%
1
 100.0%
27
  96.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 1 participants 28 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black (or African American)
1
   7.7%
4
  28.6%
0
   0.0%
5
  17.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
12
  92.3%
9
  64.3%
1
 100.0%
22
  78.6%
Other
0
   0.0%
1
   7.1%
0
   0.0%
1
   3.6%
Intact Parathyroid Hormone (iPTH)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  pg/mL
Number Analyzed 13 participants 14 participants 1 participants 28 participants
Extension study baseline
1432.69
(800.19 to 1695.48)
1001.35
(525.76 to 1292.08)
907.74
(907.74 to 907.74)
1047.41
(583.37 to 1530.03)
Day 1 of cinacalcet treatment baseline
1432.69
(800.19 to 1695.48)
798.10
(622.36 to 1360.95)
992.60
(992.60 to 992.60)
980.56
(639.85 to 1530.03)
[1]
Measure Description: Intact parathyroid hormone levels are reported for the extension study baseline and also for baseline relative to day 1 of cinacalcet treatment (equivalent to baseline of extension study for participants who received SOC alone in parent study 20130356; transferred from parent study for all other participants).
Corrected Total Serum Calcium   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 13 participants 14 participants 1 participants 28 participants
Extension study baseline
9.56
(9.40 to 10.00)
9.93
(9.02 to 10.16)
10.29
(10.29 to 10.29)
9.80
(9.36 to 10.18)
Day 1 of cinacalcet treatment baseline
9.56
(9.40 to 10.00)
9.86
(9.58 to 10.18)
10.90
(10.90 to 10.90)
9.80
(9.45 to 10.19)
[1]
Measure Description:

Total serum calcium was corrected using the following formula if the serum albumin was < 4 g/dL:

Corrected total serum calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 – serum albumin (g/dL)) Corrected calcium levels are reported for the extension study baseline and also for baseline relative to day 1 of cinacalcet treatment (equivalent to baseline of extension study for participants who received SOC alone in parent study 20130356; transferred from parent study for all other participants).

Ionized Calcium  
Median (Inter-Quartile Range)
Unit of measure:  mmol/L
Number Analyzed 13 participants 14 participants 1 participants 28 participants
Extension study baseline
1.130
(1.110 to 1.230)
1.145
(1.100 to 1.280)
1.390
(1.390 to 1.390)
1.140
(1.110 to 1.260)
Day 1 of cinacalcet treatment baseline
1.130
(1.110 to 1.230)
1.225
(1.140 to 1.270)
1.340
(1.340 to 1.340)
1.215
(1.125 to 1.260)
Serum Phosphorus   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 13 participants 14 participants 1 participants 28 participants
Extension study baseline
5.57
(4.86 to 6.19)
6.05
(5.31 to 6.67)
8.08
(8.08 to 8.08)
5.85
(5.23 to 6.58)
Day 1 of cinacalcet treatment baseline
5.57
(4.86 to 6.19)
5.75
(4.88 to 6.13)
9.00
(9.00 to 9.00)
5.74
(4.87 to 6.32)
[1]
Measure Description: Phosphorus levels are reported for the extension study baseline and also for baseline relative to day 1 of cinacalcet treatment (equivalent to baseline of extension study for participants who received SOC alone in parent study 20130356; transferred from parent study for all other participants).
Calcium Phosphorus Product (Ca x P)  
Median (Inter-Quartile Range)
Unit of measure:  mg²/dL²
Number Analyzed 13 participants 14 participants 1 participants 28 participants
Extension study baseline
54.42
(48.59 to 58.82)
57.80
(50.94 to 65.65)
82.28
(82.28 to 82.28)
56.71
(50.11 to 65.06)
Day 1 of cinacalcet treatment baseline
54.42
(48.59 to 58.82)
57.98
(47.47 to 62.25)
98.90
(98.90 to 98.90)
56.81
(48.03 to 62.24)
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.0). The investigator assessed whether the adverse event was possibly related to the study drug as indicated by a “yes” or “no” response to the question: Is there a reasonable possibility that the event may have been caused by the study drug?
Time Frame From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug in the extension study.
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13 14 1
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event (AE)
9
  69.2%
10
  71.4%
1
 100.0%
AE Grade ≥ 2
2
  15.4%
7
  50.0%
1
 100.0%
AE Grade ≥ 3
2
  15.4%
6
  42.9%
1
 100.0%
AE Grade ≥ 4
0
   0.0%
0
   0.0%
1
 100.0%
Serious adverse event (SAE)
2
  15.4%
6
  42.9%
1
 100.0%
AE leading to discontinuation of study drug
0
   0.0%
0
   0.0%
0
   0.0%
Fatal adverse events
0
   0.0%
0
   0.0%
1
 100.0%
Treatment-related adverse events (TRAE)
5
  38.5%
4
  28.6%
0
   0.0%
Treatment-related AE Grade ≥ 2
0
   0.0%
1
   7.1%
0
   0.0%
Treatment-related AE Grade ≥ 3
0
   0.0%
0
   0.0%
0
   0.0%
Treatment-related AE Grade ≥ 4
0
   0.0%
0
   0.0%
0
   0.0%
Treatment-related serious adverse events
0
   0.0%
0
   0.0%
0
   0.0%
TRAE leading to discontinuation of study drug
0
   0.0%
0
   0.0%
0
   0.0%
Fatal treatment-related adverse events
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15
Hide Description

This endpoint was analyzed in participants who received SOC only in parent study 20130356.

Participants who had no iPTH values during weeks 11 or 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded.

Time Frame Baseline (defined as the mean values of samples collected during the screening period and day 1 pre-dose in the extension study) and weeks 11 and 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants from Study 20130356 who did not receive cinacalcet prior to day 1 of the extension study and had ≥ 1 assessment after day 1 of the extension study.
Arm/Group Title 20130356 SOC
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.8
(9.1 to 61.4)
3.Secondary Outcome
Title Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28
Hide Description

This endpoint was analyzed in participants who received SOC only in parent study 20130356.

For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.

Time Frame Extension study baseline and weeks 23 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants from Study 20130356 who did not receive cinacalcet prior to day 1 of the extension study and had ≥ 1 assessment after day 1 of the extension study.
Arm/Group Title 20130356 SOC
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.1
(5.0 to 53.8)
4.Secondary Outcome
Title Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28
Hide Description

This endpoint was analyzed in participants who received SOC only in parent study 20130356.

For participants who had no values during week 23 and week 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.

Time Frame Extension study baseline and weeks 23 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants from Study 20130356 who did not receive cinacalcet prior to day 1 of the extension study and had ≥ 1 assessment after day 1 of the extension study.
Arm/Group Title 20130356 SOC
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: percent change
11.43
(-20.64 to 27.27)
5.Secondary Outcome
Title Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28
Hide Description For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame Weeks 23 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13 14 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.7
(0.2 to 36.0)
21.4
(4.7 to 50.8)
0.0
(0.0 to 97.5)
6.Secondary Outcome
Title Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28
Hide Description For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame Extension study baseline and weeks 23 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13 14 1
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
-0.24
(-0.46 to -0.06)
-0.24
(-0.81 to 0.58)
-0.74
(-0.74 to -0.74)
7.Secondary Outcome
Title Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28
Hide Description For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame Extension study baseline and weeks 23 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13 14 1
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
0.19
(-0.52 to 0.56)
-0.08
(-1.41 to 0.17)
0.82
(0.82 to 0.82)
8.Secondary Outcome
Title Serum Corrected Calcium at Baseline, Week 11, and Week 28
Hide Description Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame Extension study baseline, week 11 and week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13 14 1
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Extension study baseline Number Analyzed 13 participants 14 participants 1 participants
9.56
(9.40 to 10.00)
9.93
(9.02 to 10.16)
10.29
(10.29 to 10.29)
Week 11 Number Analyzed 12 participants 12 participants 0 participants
9.35
(9.20 to 9.60)
9.85
(9.30 to 10.65)
Week 28 Number Analyzed 9 participants 12 participants 0 participants
9.50
(9.30 to 10.00)
9.90
(9.10 to 10.25)
9.Secondary Outcome
Title Serum Phosphorus at Baseline, Week 11, and Week 28
Hide Description Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame Extension study baseline, week 11 and week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13 14 1
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
Extension study baseline Number Analyzed 13 participants 14 participants 1 participants
5.57
(4.86 to 6.19)
6.05
(5.31 to 6.67)
8.08
(8.08 to 8.08)
Week 11 Number Analyzed 12 participants 12 participants 0 participants
5.25
(4.55 to 5.80)
6.20
(5.55 to 7.30)
Week 28 Number Analyzed 9 participants 10 participants 0 participants
5.00
(4.30 to 5.60)
5.95
(5.70 to 6.80)
10.Secondary Outcome
Title Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15
Hide Description

The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356.

Participants who had no iPTH values during weeks 11 and 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded.

Time Frame Baseline and weeks 11 and 15, relative to day 1 of cinacalcet treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13 14 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.8
(9.1 to 61.4)
35.7
(12.8 to 64.9)
100.0
(2.5 to 100.0)
11.Secondary Outcome
Title Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28
Hide Description

The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356.

For participants who did not have an iPTH value during weeks 23 and 28, the mean of the last two available post-baseline values collected at protocol-specified visits was used. If only one post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.

Time Frame Baseline and weeks 23 and 28, relative to day 1 of cinacalcet treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13 14 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.1
(5.0 to 53.8)
35.7
(12.8 to 64.9)
0.0
(0.0 to 97.5)
12.Secondary Outcome
Title Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time
Hide Description

Percent change in iPTH measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356.

Data collected more than 7 days after the last dose of study drug were excluded.

Time Frame Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13 14 1
Median (Inter-Quartile Range)
Unit of Measure: percent change
Week 3 Number Analyzed 13 participants 14 participants 1 participants
10.16
(-4.42 to 20.24)
-6.88
(-30.86 to 41.81)
55.54
(55.54 to 55.54)
Week 7 Number Analyzed 13 participants 13 participants 1 participants
1.99
(-37.82 to 17.42)
-4.96
(-40.93 to 32.44)
9.78
(9.78 to 9.78)
Week 11 Number Analyzed 12 participants 13 participants 1 participants
19.75
(-27.88 to 84.96)
-7.64
(-30.77 to 13.37)
-7.00
(-7.00 to -7.00)
Week 15 Number Analyzed 12 participants 14 participants 1 participants
-7.67
(-59.96 to 51.23)
-13.04
(-68.59 to 10.74)
-73.85
(-73.85 to -73.85)
Week 17 Number Analyzed 2 participants 12 participants 1 participants
-23.93
(-59.61 to 11.75)
-3.09
(-40.52 to 21.40)
-20.02
(-20.02 to -20.02)
Week 18 Number Analyzed 0 participants 12 participants 1 participants
-29.85
(-54.42 to 31.15)
-7.49
(-7.49 to -7.49)
Week 19 Number Analyzed 10 participants 12 participants 0 participants
-37.17
(-69.24 to 21.47)
-3.50
(-50.02 to 19.16)
Week 20 Number Analyzed 1 participants 11 participants 1 participants
-13.12
(-13.12 to -13.12)
0.44
(-35.10 to 66.13)
160.80
(160.80 to 160.80)
Week 23 Number Analyzed 10 participants 14 participants 0 participants
-9.05
(-52.43 to 28.64)
-6.65
(-35.13 to 83.11)
Week 27 Number Analyzed 10 participants 13 participants 0 participants
-8.50
(-69.20 to 18.78)
16.36
(-59.79 to 50.23)
Week 31 Number Analyzed 0 participants 13 participants 0 participants
32.30
(-58.73 to 75.48)
Week 35 Number Analyzed 0 participants 12 participants 0 participants
16.82
(-70.15 to 82.83)
Week 39 Number Analyzed 0 participants 12 participants 0 participants
0.09
(-58.27 to 86.94)
Week 43 Number Analyzed 0 participants 12 participants 0 participants
-17.13
(-47.15 to 47.30)
Week 48 Number Analyzed 0 participants 10 participants 0 participants
-45.67
(-66.01 to 33.64)
Week 52 Number Analyzed 0 participants 1 participants 0 participants
86.50
(86.50 to 86.50)
End of treatment Number Analyzed 10 participants 12 participants 0 participants
-8.50
(-69.20 to 18.78)
-45.67
(-74.62 to 34.62)
End of study Number Analyzed 1 participants 1 participants 0 participants
105.27
(105.27 to 105.27)
20.21
(20.21 to 20.21)
13.Secondary Outcome
Title Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time
Hide Description

Change in corrected calcium measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356.

Data collected more than 7 days after the last dose of study drug were excluded.

Time Frame Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13 14 1
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Week 3 Number Analyzed 13 participants 14 participants 1 participants
-0.18
(-0.26 to -0.11)
0.19
(0.05 to 0.32)
-0.1
(-0.1 to -0.1)
Week 7 Number Analyzed 13 participants 13 participants 1 participants
-0.34
(-0.44 to -0.24)
-0.01
(-0.23 to 0.21)
-0.5
(-0.5 to -0.5)
Week 11 Number Analyzed 12 participants 13 participants 1 participants
-0.35
(-0.46 to -0.24)
-0.06
(-0.19 to 0.07)
-0.5
(-0.5 to -0.5)
Week 15 Number Analyzed 12 participants 14 participants 1 participants
-0.37
(-0.62 to -0.12)
0.06
(-0.18 to 0.30)
0.5
(0.5 to 0.5)
Week 17 Number Analyzed 2 participants 12 participants 1 participants
-0.02
(-0.24 to 0.20)
-0.11
(-0.45 to 0.22)
-0.8
(-0.8 to -0.8)
Week 18 Number Analyzed 0 participants 12 participants 1 participants
-0.17
(-0.35 to 0.02)
-0.3
(-0.3 to -0.3)
Week 19 Number Analyzed 10 participants 12 participants 1 participants
-0.43
(-0.60 to -0.26)
-0.20
(-0.37 to -0.03)
-0.1
(-0.1 to -0.1)
Week 20 Number Analyzed 0 participants 12 participants 0 participants
-0.01
(-0.18 to 0.16)
Week 21 Number Analyzed 0 participants 9 participants 1 participants
-0.36
(-0.63 to -0.09)
-2.6
(-2.6 to -2.6)
Week 23 Number Analyzed 9 participants 12 participants 0 participants
-0.18
(-0.24 to -0.12)
-0.20
(-0.47 to 0.08)
Week 27 Number Analyzed 9 participants 13 participants 0 participants
-0.14
(-0.25 to -0.02)
-0.24
(-0.41 to -0.07)
Week 31 Number Analyzed 0 participants 13 participants 0 participants
-0.00
(-0.20 to 0.19)
Week 35 Number Analyzed 0 participants 12 participants 0 participants
-0.42
(-0.57 to -0.26)
Week 39 Number Analyzed 0 participants 12 participants 0 participants
-0.63
(-0.84 to -0.43)
Week 43 Number Analyzed 0 participants 12 participants 0 participants
-0.37
(-0.63 to -0.11)
Week 48 Number Analyzed 0 participants 10 participants 0 participants
-0.55
(-0.87 to -0.23)
Week 52 Number Analyzed 0 participants 1 participants 0 participants
-0.16
(-0.16 to -0.16)
End of treatment Number Analyzed 9 participants 12 participants 0 participants
0.18
(0.02 to 0.34)
-0.04
(-0.26 to 0.18)
End of study Number Analyzed 1 participants 0 participants 0 participants
1.00
(1.00 to 1.00)
14.Secondary Outcome
Title Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time
Hide Description

Change in phosphorus measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356.

Data collected more than 7 days after the last dose of study drug were excluded.

Time Frame Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet
Hide Arm/Group Description:
Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Overall Number of Participants Analyzed 13 14 1
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Week 3 Number Analyzed 13 participants 14 participants 1 participants
-0.24
(-0.56 to -0.08)
0.81
(-0.54 to 1.07)
5.6
(5.6 to 5.6)
Week 7 Number Analyzed 13 participants 13 participants 1 participants
-0.16
(-0.50 to 0.17)
0.37
(0.10 to 0.64)
0.3
(0.3 to 0.3)
Week 11 Number Analyzed 12 participants 12 participants 1 participants
0.01
(-0.33 to 0.36)
1.17
(0.87 to 1.47)
0
(0 to 0)
Week 15 Number Analyzed 12 participants 14 participants 1 participants
-0.52
(-0.79 to -0.25)
0.96
(0.71 to 1.20)
-1.9
(-1.9 to -1.9)
Week 17 Number Analyzed 2 participants 12 participants 0 participants
-0.08
(-0.19 to 0.03)
1.57
(0.96 to 2.19)
Week 18 Number Analyzed 0 participants 12 participants 1 participants
0.61
(0.30 to 0.93)
-0.9
(-0.9 to -0.9)
Week 19 Number Analyzed 10 participants 12 participants 1 participants
-0.45
(-0.74 to -0.16)
0.91
(0.37 to 1.44)
-0.3
(-0.3 to -0.3)
Week 20 Number Analyzed 0 participants 11 participants 0 participants
0.84
(0.16 to 1.51)
Week 21 Number Analyzed 0 participants 9 participants 1 participants
0.17
(-0.67 to 1.01)
0.1
(0.1 to 0.1)
Week 23 Number Analyzed 9 participants 12 participants 0 participants
-0.37
(-0.78 to 0.05)
0.55
(0.12 to 0.98)
Week 27 Number Analyzed 9 participants 13 participants 0 participants
-0.18
(-0.53 to 0.18)
0.76
(0.27 to 1.24)
Week 31 Number Analyzed 0 participants 13 participants 0 participants
0.83
(0.24 to 1.42)
Week 35 Number Analyzed 0 participants 12 participants 0 participants
-0.03
(-0.51 to 0.45)
Week 39 Number Analyzed 0 participants 12 participants 0 participants
0.40
(-0.11 to 0.91)
Week 43 Number Analyzed 0 participants 12 participants 0 participants
0.33
(-0.21 to 0.86)
Week 48 Number Analyzed 0 participants 8 participants 0 participants
0.60
(-0.21 to 1.42)
Week 52 Number Analyzed 0 participants 1 participants 0 participants
0.61
(0.61 to 0.61)
End of treatment Number Analyzed 9 participants 10 participants 0 participants
-0.18
(-0.53 to 0.18)
0.43
(-0.25 to 1.11)
End of study Number Analyzed 1 participants 0 participants 0 participants
1.20
(1.20 to 1.20)
Time Frame From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title 20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet Total
Hide Arm/Group Description Participants who received standard of care (SOC) in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was 0.20 mg/kg/day. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. Participants who received SOC and cinacalcet in parent study 20130356 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. Participants who received SOC and cinacalcet in parent study 2011100 received cinacalcet daily for up to 28 weeks in this extension study. The starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. All participants who received cinacalcet in study 20140159.
All-Cause Mortality
20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/14 (0.00%)   1/1 (100.00%)   1/28 (3.57%) 
Show Serious Adverse Events Hide Serious Adverse Events
20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/13 (15.38%)   6/14 (42.86%)   1/1 (100.00%)   9/28 (32.14%) 
Blood and lymphatic system disorders         
Anaemia  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Endocrine disorders         
Goitre  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Gastrointestinal disorders         
Gastroduodenitis  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
General disorders         
Fatigue  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Local swelling  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Pyrexia  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Infections and infestations         
Cellulitis  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Device related infection  1  0/13 (0.00%)  2/14 (14.29%)  0/1 (0.00%)  2/28 (7.14%) 
Pericarditis infective  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Pneumonia  1  0/13 (0.00%)  0/14 (0.00%)  1/1 (100.00%)  1/28 (3.57%) 
Staphylococcal infection  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Urinary tract infection  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Product Issues         
Device damage  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Device dislocation  1  0/13 (0.00%)  1/14 (7.14%)  1/1 (100.00%)  2/28 (7.14%) 
Respiratory, thoracic and mediastinal disorders         
Tachypnoea  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Surgical and medical procedures         
Catheter placement  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Vascular disorders         
Venous occlusion  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
20130356 SOC 20130356 SOC + Cinacalcet 20110100 SOC + Cinacalcet Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/13 (69.23%)   10/14 (71.43%)   1/1 (100.00%)   20/28 (71.43%) 
Cardiac disorders         
Left ventricular hypertrophy  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Tachycardia  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Endocrine disorders         
Goitre  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Hyperparathyroidism secondary  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Gastrointestinal disorders         
Abdominal pain  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Abdominal pain upper  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Constipation  1  1/13 (7.69%)  1/14 (7.14%)  0/1 (0.00%)  2/28 (7.14%) 
Diarrhoea  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Duodenogastric reflux  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Gastritis erosive  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Gastroduodenitis  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Nausea  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Vomiting  1  0/13 (0.00%)  2/14 (14.29%)  0/1 (0.00%)  2/28 (7.14%) 
General disorders         
Chest pain  1  1/13 (7.69%)  1/14 (7.14%)  0/1 (0.00%)  2/28 (7.14%) 
Complication associated with device  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Local swelling  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Mass  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Nodule  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Peripheral swelling  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Pyrexia  1  0/13 (0.00%)  2/14 (14.29%)  0/1 (0.00%)  2/28 (7.14%) 
Immune system disorders         
Hypersensitivity  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Infections and infestations         
Herpes virus infection  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Nasopharyngitis  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Pyelonephritis  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Rhinitis  1  0/13 (0.00%)  2/14 (14.29%)  0/1 (0.00%)  2/28 (7.14%) 
Upper respiratory tract infection  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Urinary tract infection  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Injury, poisoning and procedural complications         
Arteriovenous fistula site complication  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Contusion  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Heat exhaustion  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Ligament sprain  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Procedural pain  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Ulna fracture  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Investigations         
Adjusted calcium decreased  1  1/13 (7.69%)  1/14 (7.14%)  0/1 (0.00%)  2/28 (7.14%) 
Alanine aminotransferase increased  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Aspartate aminotransferase increased  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Blood alkaline phosphatase increased  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Blood calcium decreased  1  1/13 (7.69%)  1/14 (7.14%)  0/1 (0.00%)  2/28 (7.14%) 
Blood parathyroid hormone decreased  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
C-reactive protein increased  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Haemoglobin decreased  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Red blood cell sedimentation rate increased  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Weight decreased  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Metabolism and nutrition disorders         
Hypercalcaemia  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Hyperkalaemia  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Hypocalcaemia  1  2/13 (15.38%)  1/14 (7.14%)  0/1 (0.00%)  3/28 (10.71%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Joint swelling  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Muscle spasms  1  2/13 (15.38%)  0/14 (0.00%)  0/1 (0.00%)  2/28 (7.14%) 
Musculoskeletal pain  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Musculoskeletal stiffness  1  1/13 (7.69%)  1/14 (7.14%)  0/1 (0.00%)  2/28 (7.14%) 
Osteoarthritis  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Pain in extremity  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Nervous system disorders         
Dizziness  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Headache  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Loss of consciousness  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Paraesthesia  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Tremor  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
Psychiatric disorders         
Major depression  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Staring  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Dyspnoea  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Pulmonary calcification  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Skin and subcutaneous tissue disorders         
Pain of skin  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Pruritus  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Rash  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Surgical and medical procedures         
Catheter placement  1  0/13 (0.00%)  1/14 (7.14%)  0/1 (0.00%)  1/28 (3.57%) 
Vascular disorders         
Hypertension  1  0/13 (0.00%)  0/14 (0.00%)  1/1 (100.00%)  1/28 (3.57%) 
Venous haemorrhage  1  1/13 (7.69%)  0/14 (0.00%)  0/1 (0.00%)  1/28 (3.57%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02341417     History of Changes
Other Study ID Numbers: 20140159
2014-003563-38 ( EudraCT Number )
First Submitted: December 2, 2014
First Posted: January 19, 2015
Results First Submitted: March 7, 2018
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018