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Trial record 46 of 108 for:    CALCIUM CATION

Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism

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ClinicalTrials.gov Identifier: NCT01439867
Recruitment Status : Terminated (Amgen decided to terminate the study early to be able to meet US regulatory timelines fo filing. Subjects in treatment were rolled over to the 20140159 study.)
First Posted : September 23, 2011
Results First Posted : August 11, 2017
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Kidney Disease
Hyperparathyroidism, Secondary
Interventions Drug: Cinacalcet hydrochloride
Drug: Standard of Care
Enrollment 18
Recruitment Details The study was conducted at 14 study centers in Czech Republic (1 site), France (1 site), Germany (1 site), Italy (1 site), Slovakia (1 site), Poland (3 sites), and the United States (6 sites). The first participant was enrolled on 22 June 2012, and the last participant completed the study on 03 June 2016.
Pre-assignment Details Because of changes to the study design that were implemented after the partial clinical hold, data are presented overall and for 2 cohorts: participants enrolled before the partial clinical hold (Cohort 1) and participants enrolled after the partial clinical hold (Cohort 2).
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg. Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Period Title: Overall Study
Started 8 10
Received Treatment 7 10
Completed 2 2
Not Completed 6 8
Reason Not Completed
Non-compliance             0             1
Withdrawal by Subject             1             2
Administrative Decision             4             5
Protocol-specified Criteria             1             0
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg. Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower. Total of all reporting groups
Overall Number of Baseline Participants 8 10 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 8 participants 10 participants 18 participants
37.1  (18.9) 35.0  (15.9) 35.9  (16.8)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 18 participants
28 days to < 2 years 2 1 3
2 years to < 6 years 6 9 15
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 18 participants
Female
3
  37.5%
3
  30.0%
6
  33.3%
Male
5
  62.5%
7
  70.0%
12
  66.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 18 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Black or African American 1 1 2
Native Hawaiian or Other Pacific Islander 0 0 0
White 6 9 15
Other 1 0 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 18 participants
Hispanic or Latino 1 2 3
Not Hispanic or Latino 7 8 15
Corrected Serum Calcium  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 8 participants 10 participants 18 participants
10.56  (0.75) 9.82  (0.61) 10.15  (0.76)
Intact Parathyroid Hormone  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 8 participants 10 participants 18 participants
1414.34  (699.90) 1206.92  (597.85) 1299.11  (634.18)
1.Primary Outcome
Title Percentage of Participants With Hypocalcemia
Hide Description Hypocalcemia was defined as corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to < 6 years at any time during the study.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included participants who received at least 1 dose of cinacalcet and had at least 1 measured serum calcium value while on cinacalcet (calcium analysis set).
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description:
Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Participants received cinacalcet administered daily for 24 weeks.
Overall Number of Participants Analyzed 7 10 17
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 34.8)
0.0
(0.0 to 25.9)
0.0
(0.0 to 16.2)
2.Secondary Outcome
Title Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study
Hide Description [Not Specified]
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included participants who received at least 1 dose of cinacalcet and had at least 1 measured serum calcium value while on cinacalcet (calcium analysis set).
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description:
Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Participants received cinacalcet administered daily for 24 weeks.
Overall Number of Participants Analyzed 7 10 17
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
14.3
(0.7 to 52.1)
10.0
(0.5 to 39.4)
11.8
(2.1 to 32.6)
3.Secondary Outcome
Title Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Hide Description [Not Specified]
Time Frame Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description:
Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Participants received cinacalcet administered daily for 24 weeks.
Overall Number of Participants Analyzed 7 10 17
Mean (Standard Deviation)
Unit of Measure: percent change
Week 3 (n = 7, 9, 16) -22.96  (64.67) -3.37  (54.82) -11.94  (58.11)
Week 7 (n = 4, 9, 13) 3.87  (110.94) -3.13  (52.94) -0.98  (70.40)
Week 11 (n = 4, 8, 12) -51.70  (27.18) -7.15  (75.30) -22.00  (65.51)
Week 15 (n = 2, 7, 9) -65.31  (6.83) -51.69  (39.91) -54.71  (35.16)
Week 19 (n = 1, 3, 4) -79.02 [1]   (NA) -57.35  (32.86) -62.76  (28.93)
Week 22 (n = 0, 1, 1) NA [2]   (NA) -78.04 [1]   (NA) -78.04 [1]   (NA)
Week 24 (n = 0, 1, 1) NA [2]   (NA) -67.42 [1]   (NA) -67.42 [1]   (NA)
[1]
Could not be calculated for a sample size = 1
[2]
No participants with available data
4.Secondary Outcome
Title Percent Change From Baseline in Corrected Serum Calcium
Hide Description [Not Specified]
Time Frame Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description:
Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Participants received cinacalcet administered daily for 24 weeks.
Overall Number of Participants Analyzed 7 10 17
Mean (Standard Deviation)
Unit of Measure: percent change
Week 3 (n = 7, 10, 17) -0.50  (4.47) 3.43  (6.38) 1.81  (5.86)
Week 7 (n = 4, 8, 12) -3.58  (12.23) 3.60  (9.31) 1.21  (10.41)
Week 11 (n = 4, 8, 12) -3.23  (10.51) 1.46  (5.24) -0.10  (7.28)
Week 15 (n = 2, 7, 9) -6.86  (12.44) 2.99  (5.09) 0.80  (7.59)
Week 19 (n = 1, 3, 4) 1.94 [1]   (NA) -0.49  (6.62) 0.12  (5.54)
Week 22 (n = 0, 1, 1) NA [2]   (NA) 5.88 [1]   (NA) 5.88 [1]   (NA)
Week 24 (n = 0, 1, 1) NA [2]   (NA) 2.94 [1]   (NA) 2.94 [1]   (NA)
[1]
Could not be calculated for a sample size of 1
[2]
No participants with available data
5.Secondary Outcome
Title Percent Change From Baseline in Serum Phosphorous
Hide Description [Not Specified]
Time Frame Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description:
Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Participants received cinacalcet administered daily for 24 weeks.
Overall Number of Participants Analyzed 7 10 17
Mean (Standard Deviation)
Unit of Measure: percent change
Week 3 (n = 7, 10, 17) -10.75  (32.49) -5.11  (39.32) -7.43  (35.69)
Week 7 (n = 4, 8, 12) -8.68  (20.88) -9.60  (29.79) -9.29  (26.15)
Week 11 (n = 4, 8, 12) 14.39  (22.18) 4.54  (39.08) 7.82  (33.61)
Week 15 (n = 2, 7, 9) 13.99  (26.33) -16.07  (28.14) -9.39  (29.26)
Week 19 (n = 1, 2, 3) 10.87 [1]   (NA) 3.45  (4.88) 5.92  (5.50)
Week 22 (n = 0, 1, 1) NA [2]   (NA) -1.72 [3]   (NA) -1.72 [3]   (NA)
Week 24 (n = 0, 1, 1) NA [2]   (NA) 8.62 [3]   (NA) 8.62 [3]   (NA)
[1]
Could not be calculated for sample size of 1
[2]
No participants with available data
[3]
Could not be calculated for a sample size of 1
6.Secondary Outcome
Title Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)
Hide Description [Not Specified]
Time Frame Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description:
Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Participants received cinacalcet administered daily for 24 weeks.
Overall Number of Participants Analyzed 7 10 17
Mean (Standard Deviation)
Unit of Measure: percent change
Week 3 (n = 7, 10, 17) -1.89  (39.00) -2.72  (38.08) -2.37  (37.23)
Week 7 (n = 4, 8, 12) -11.56  (26.35) -6.83  (29.97) -8.40  (27.68)
Week 11 (n = 4, 8, 12) 9.48  (17.84) 5.74  (38.78) 6.99  (32.36)
Week 15 (n = 2, 7, 9) 7.58  (38.39) -14.24  (28.24) -9.39  (29.58)
Week 19 (n = 1, 2, 3) 12.34 [1]   (NA) 6.41  (9.06) 8.39  (7.27)
Week 22 (n = 0, 1, 1) NA [2]   (NA) 3.37 [1]   (NA) 3.37 [1]   (NA)
Week 24 (n = 0, 1, 1) NA [2]   (NA) 10.96 [1]   (NA) 10.96 [1]   (NA)
[1]
Could not be calculated for a sample size of 1
[2]
No participants with available data
7.Secondary Outcome
Title Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements
Hide Description A participant was considered to have achieved > 30% reduction in iPTH from baseline at any 2 consecutive measurements if percent change of any two consecutive post-baseline iPTH values were < -30% regardless if there was a missing value in between.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description:
Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Participants received cinacalcet administered daily for 24 weeks.
Overall Number of Participants Analyzed 7 10 17
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
57.1
(22.5 to 87.1)
40.0
(15.0 to 69.6)
47.1
(26.0 to 68.9)
8.Secondary Outcome
Title Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study
Hide Description A participant was considered to have achieved ≥ 30% reduction in iPTH if the percent change of any post-baseline iPTH value was ≤ -30% from baseline.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description:
Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Participants received cinacalcet administered daily for 24 weeks.
Overall Number of Participants Analyzed 7 10 17
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(65.2 to 100.0)
50.0
(22.2 to 77.8)
70.6
(47.8 to 87.6)
9.Secondary Outcome
Title Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements
Hide Description A participant was considered to have achieved iPTH between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any 2 consecutive measurements if any two consecutive post-baseline iPTH values were within the range regardless if there was a missing value in between. The analysis included all enrolled subjects with at least 1 post-baseline assessment.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description:
Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Participants received cinacalcet administered daily for 24 weeks.
Overall Number of Participants Analyzed 7 10 17
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 34.8)
10.0
(0.5 to 39.4)
5.9
(0.3 to 25.0)
10.Secondary Outcome
Title Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study
Hide Description A participant was considered to have achieved iPTH < 300 pg/mL (31.8 pmol/L) during the study if any post-baseline iPTH value was < 300 pg/mL.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included all enrolled subjects with at least 1 post-baseline assessment (full analysis set).
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description:
Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Participants received cinacalcet administered daily for 24 weeks.
Overall Number of Participants Analyzed 7 10 17
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
57.1
(22.5 to 87.1)
50.0
(22.2 to 77.8)
52.9
(31.1 to 74.0)
11.Secondary Outcome
Title Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic/ Pharmacodynamic (PK/PD) analysis set includes all participants who received at least one dose of study drug and had at least one evaluable PK parameter.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Overall Number of Participants Analyzed 3 7
Mean (Standard Deviation)
Unit of Measure: ng/mL/(mgkg)
15.1  (16.6) 17.8  (10.0)
12.Secondary Outcome
Title Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic/ Pharmacodynamic (PK/PD) analysis set includes all participants who received at least one dose of study drug and had at least one evaluable PK parameter.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg.
Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower.
Overall Number of Participants Analyzed 2 6
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL/(mgkg)
160  (195) 176.8  (177)
Time Frame 26 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 Cohort 1 Cohort 2 Total
Hide Arm/Group Description Cohort 1 consists of participants enrolled before the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.25 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms; the maximum allowed daily dose was 4.2 mg/kg. Cohort 2 consists of participants enrolled after the partial clinical hold. Participants received cinacalcet administered daily for 24 weeks. The starting dose was 0.20 mg/kg (based on dry weight) with dose adjustments and withholding based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms; the maximum allowed daily dose was 2.5 mg/kg/day or 60 mg, whichever was lower. Participants received cinacalcet administered daily for 24 weeks.
All-Cause Mortality
Cohort 1 Cohort 2 Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 Cohort 2 Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/7 (57.14%)   5/10 (50.00%)   9/17 (52.94%) 
Gastrointestinal disorders       
Diarrhoea  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Ileus  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
General disorders       
Complication associated with device  1  1/7 (14.29%)  1/10 (10.00%)  2/17 (11.76%) 
Infections and infestations       
Adenovirus infection  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Device related infection  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Device related sepsis  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Influenza  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Upper respiratory tract infection  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Injury, poisoning and procedural complications       
Overdose  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Peritoneal dialysis complication  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Metabolism and nutrition disorders       
Dehydration  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Failure to thrive  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Hyperglycaemia  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Nervous system disorders       
Seizure  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Product Issues       
Device malfunction  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Vascular disorders       
Hypertension  1  1/7 (14.29%)  1/10 (10.00%)  2/17 (11.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Cohort 2 Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/7 (71.43%)   9/10 (90.00%)   14/17 (82.35%) 
Blood and lymphatic system disorders       
Anaemia  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Ear and labyrinth disorders       
Ear pain  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Eye disorders       
Eye pain  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorders       
Constipation  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Diarrhoea  1  1/7 (14.29%)  1/10 (10.00%)  2/17 (11.76%) 
Nausea  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Vomiting  1  2/7 (28.57%)  2/10 (20.00%)  4/17 (23.53%) 
General disorders       
Asthenia  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Complication associated with device  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Pain  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Pyrexia  1  1/7 (14.29%)  2/10 (20.00%)  3/17 (17.65%) 
Infections and infestations       
Bronchitis  1  2/7 (28.57%)  0/10 (0.00%)  2/17 (11.76%) 
Device related sepsis  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Laryngitis  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Peritonitis  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Pharyngitis  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Upper respiratory tract infection  1  1/7 (14.29%)  3/10 (30.00%)  4/17 (23.53%) 
Viral infection  1  2/7 (28.57%)  0/10 (0.00%)  2/17 (11.76%) 
Viral upper respiratory tract infection  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Investigations       
Platelet count decreased  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Metabolism and nutrition disorders       
Acidosis  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Hypocalcaemia  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Hypophosphataemia  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Nervous system disorders       
Lethargy  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Unresponsive to stimuli  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/7 (14.29%)  3/10 (30.00%)  4/17 (23.53%) 
Nasal congestion  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders       
Dermatitis contact  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Erythema  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Pruritus  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Surgical and medical procedures       
Catheter removal  1  1/7 (14.29%)  0/10 (0.00%)  1/17 (5.88%) 
Vascular disorders       
Hypertension  1  1/7 (14.29%)  1/10 (10.00%)  2/17 (11.76%) 
Hypotension  1  0/7 (0.00%)  1/10 (10.00%)  1/17 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01439867     History of Changes
Other Study ID Numbers: 20110100
2011-004618-40 ( EudraCT Number )
First Submitted: September 22, 2011
First Posted: September 23, 2011
Results First Submitted: July 13, 2017
Results First Posted: August 11, 2017
Last Update Posted: June 13, 2019