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Trial record 83 of 108 for:    CALCIUM CATION

Pediatric Chronic Kidney Disease Safety and Efficacy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01277510
Recruitment Status : Terminated (Study was suspended in agreement between sponsor and FDA due to concerns about the study design after a fatality had occurred in the presence of hypocalcemia.)
First Posted : January 17, 2011
Results First Posted : May 15, 2015
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Kidney Disease
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Disease
Secondary Hyperparathyroidism
Interventions Drug: cinacalcet capsule
Drug: placebo
Drug: Standard of Care
Enrollment 43
Recruitment Details

The first patient was enrolled on 28 June 2011 and the last patient enrolled was on 15 January 2013.

Eligible participants were between the ages of 6 to less than 18 years old who had chronic kidney (CKD) and secondary hyperparathyroidism treated with either hemodialysis or peritoneal dialysis for ≥ 2 months.

Pre-assignment Details This study consisted of a 30-week randomized, double-blind phase followed by a 30-week open-label phase. Participants were randomized 1:1 to receive either cinacalcet or placebo in the double-blind phase. All participants received cinacalcet in the open-label phase.
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg. Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
Period Title: Double-blind Phase
Started 21 22
Received Investigational Product 21 22
Completed 8 [1] 4 [1]
Not Completed 13 18
Reason Not Completed
Non-compliance             0             1
Adverse Event             1             0
Withdrawal by Subject             2             0
Administrative decision             7             9
Death             0             1
Protocol-specified criteria             2             6
Other             1             1
[1]
Completed investigational product
Period Title: Open-label Phase
Started 8 4
Received Investigational Product 6 4
Completed 1 [1] 1 [1]
Not Completed 7 3
Reason Not Completed
Administrative decision             4             3
Protocol-specified criteria             1             0
Never received investigational product             2             0
[1]
Completed investigational product
Arm/Group Title Placebo Cinacalcet Total
Hide Arm/Group Description Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg. Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight. Total of all reporting groups
Overall Number of Baseline Participants 21 22 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 22 participants 43 participants
13.2  (2.9) 13.3  (3.6) 13.2  (3.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 43 participants
6 to < 12 years 5 6 11
12 to < 18 years 16 16 32
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 43 participants
Female
10
  47.6%
12
  54.5%
22
  51.2%
Male
11
  52.4%
10
  45.5%
21
  48.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 43 participants
White 15 16 31
Black or African American 6 5 11
Other 0 1 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 43 participants
Hispanic or Latino 5 3 8
Not Hispanic or Latino 16 19 35
Intact Parathyroid Hormone (iPTH)  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 21 participants 22 participants 43 participants
795.8  (537.9) 757.1  (440.1) 776.0  (484.8)
Corrected Total Serum Calcium   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 21 participants 22 participants 43 participants
9.88  (0.62) 9.91  (0.54) 9.90  (0.58)
[1]
Measure Description:

Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations:

Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 – Serum albumin (g/dL)).

Serum Phosphorous  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 21 participants 22 participants 43 participants
6.37  (1.48) 6.68  (1.78) 6.53  (1.63)
1.Primary Outcome
Title Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase
Hide Description The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
Time Frame From Baseline to the Efficacy Assessment Phase, Weeks 25-30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, which includes all randomized participants with at least 1 post-baseline assessment.
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
Overall Number of Participants Analyzed 21 22
Measure Type: Number
Unit of Measure: percentage of participants
19.0 54.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints (Outcome Measures 1-5). The primary endpoint was tested at a significance level of 0.05. The four biochemical secondary endpoints were to be tested using Holm’s method at 0.05 should the primary endpoint achieve a significant result.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -<12 years old or 12 - <18 years old).
Method of Estimation Estimation Parameter Difference (Cinacalcet - Placebo)
Estimated Value 35.50
Confidence Interval (2-Sided) 95%
8.76 to 62.24
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase
Hide Description The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
Time Frame From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
Overall Number of Participants Analyzed 21 22
Measure Type: Number
Unit of Measure: pecentage of participants
23.8 27.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was > 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if > 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -<12 years old or 12 - <18 years old).
Method of Estimation Estimation Parameter Difference (Cinacalcet - Placebo)
Estimated Value 3.46
Confidence Interval (2-Sided) 95%
-22.58 to 29.51
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period
Hide Description Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 – Serum albumin (g/dL)). The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used."
Time Frame From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
Overall Number of Participants Analyzed 21 22
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
-1.0
(-4.9 to 2.9)
-4.6
(-8.4 to -0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was > 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if > 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.147
Comments [Not Specified]
Method ANCOVA
Comments Baseline age group was used as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-8.6 to 1.3
Estimation Comments Cinacalcet-Placebo
4.Secondary Outcome
Title Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase
Hide Description The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
Time Frame From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; data for one participant in the Placebo group were not available.
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
Overall Number of Participants Analyzed 20 22
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
10.2
(-0.8 to 21.2)
4.9
(-5.5 to 15.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was > 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if > 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.454
Comments [Not Specified]
Method ANCOVA
Comments Baseline age group was used as covariate
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.3
Confidence Interval (2-Sided) 95%
-19.4 to 8.9
Estimation Comments Cinacalcet-Placebo
5.Secondary Outcome
Title Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase
Hide Description The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
Time Frame From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
Overall Number of Participants Analyzed 21 22
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
8.0
(-1.8 to 17.7)
-2.0
(-11.4 to 7.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was > 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if > 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments [Not Specified]
Method ANCOVA
Comments Baseline age group was used as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.0
Confidence Interval (2-Sided) 95%
-22.5 to 2.6
Estimation Comments Cinacalcet-Placebo
6.Secondary Outcome
Title Growth Velocity From Baseline to End of Double-blind Phase
Hide Description Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of double-blind phase visit was at Week 30 by design but the last assessment in the double-blind phase was used due to the early termination of the study.
Time Frame From Baseline to end of Efficacy Assessment at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; the last assessment in the double-blind phase was used due to the early termination of the study. Only participants with available data are included in the analysis.
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
Overall Number of Participants Analyzed 19 17
Least Squares Mean (95% Confidence Interval)
Unit of Measure: cm/year
3.1
(0.7 to 5.6)
3.3
(0.8 to 5.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.896
Comments No adjustments for multiplicity were made.
Method ANCOVA
Comments Baseline age group was used as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-3.1 to 3.6
Estimation Comments Cinacalcet-Placebo
7.Secondary Outcome
Title Growth Velocity From End of Double-blind Phase to End of Open-label Phase
Hide Description Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of open-label phase visit was at Week 60 by design but the last assessment in the open-label phase was used due to the early termination of the study.
Time Frame End of double-blind phase (Week 30) until end of the open-label phase (Week 60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Only participants with available data were included in the anaysis.
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
Overall Number of Participants Analyzed 7 3
Mean (Standard Deviation)
Unit of Measure: cm/year
2.75  (3.23) 1.21  (1.31)
8.Secondary Outcome
Title Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase
Hide Description The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
Time Frame From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; only participants with available data were included in the analysis.
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
Overall Number of Participants Analyzed 12 18
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
-1.5
(-8.6 to 5.6)
-2.3
(-8.2 to 3.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.854
Comments [Not Specified]
Method ANCOVA
Comments Baseline age group was used as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-9.4 to 7.9
Estimation Comments Cinacalcet-Placebo
Time Frame 60 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 Double-blind Phase: Placebo Double-blind Phase: Cinacalcet Open-label Phase: Previous Placebo Open-label Phase: Previous Cinacalcet
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Double-blind Phase: Placebo Double-blind Phase: Cinacalcet Open-label Phase: Previous Placebo Open-label Phase: Previous Cinacalcet
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Double-blind Phase: Placebo Double-blind Phase: Cinacalcet Open-label Phase: Previous Placebo Open-label Phase: Previous Cinacalcet
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/21 (42.86%)   9/22 (40.91%)   3/6 (50.00%)   1/4 (25.00%) 
Blood and lymphatic system disorders         
Anaemia  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Febrile neutropenia  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Neutropenia  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Cardiac disorders         
Cardiopulmonary failure  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Eye disorders         
Papilloedema  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Diarrhoea  1  2/21 (9.52%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Gastric ulcer  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Gastritis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Nausea  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Varices oesophageal  1  0/21 (0.00%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
General disorders         
Medical device complication  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Pain  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Pyrexia  1  2/21 (9.52%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Thirst  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Thrombosis in device  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Immune system disorders         
Rubber sensitivity  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Transplant rejection  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Infections and infestations         
Catheter site cellulitis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Device related infection  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Gastroenteritis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Measles  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Peritonitis  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  1/4 (25.00%) 
Pneumonia  1  0/21 (0.00%)  0/22 (0.00%)  0/6 (0.00%)  1/4 (25.00%) 
Pyelonephritis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Sepsis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Urinary tract infection  1  1/21 (4.76%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Injury, poisoning and procedural complications         
Arteriovenous fistula site complication  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Graft complication  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Overdose  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Vascular graft complication  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Investigations         
Blood creatinine increased  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Blood pressure increased  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Haemoglobin increased  1  0/21 (0.00%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Weight decreased  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders         
Acidosis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Dehydration  1  2/21 (9.52%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Fluid overload  1  1/21 (4.76%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Food intolerance  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Hyperglycaemia  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Hyperkalaemia  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Hyperphosphataemia  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Hypocalcaemia  1  0/21 (0.00%)  1/22 (4.55%)  1/6 (16.67%)  0/4 (0.00%) 
Nervous system disorders         
Hypertensive encephalopathy  1  1/21 (4.76%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Migraine  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Renal and urinary disorders         
Glycosuria  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Vascular disorders         
Hypertension  1  1/21 (4.76%)  2/22 (9.09%)  1/6 (16.67%)  0/4 (0.00%) 
Hypertensive crisis  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Hypotension  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Thrombosis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Double-blind Phase: Placebo Double-blind Phase: Cinacalcet Open-label Phase: Previous Placebo Open-label Phase: Previous Cinacalcet
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/21 (80.95%)   16/22 (72.73%)   6/6 (100.00%)   3/4 (75.00%) 
Blood and lymphatic system disorders         
Neutropenia  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Cardiac disorders         
Mitral valve stenosis  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Palpitations  1  1/21 (4.76%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Tachycardia  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Endocrine disorders         
Hyperparathyroidism  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Eye disorders         
Keratitis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Ocular hyperaemia  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders         
Abdominal distension  1  0/21 (0.00%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Abdominal pain  1  2/21 (9.52%)  3/22 (13.64%)  2/6 (33.33%)  0/4 (0.00%) 
Abdominal pain upper  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Constipation  1  3/21 (14.29%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Diarrhoea  1  2/21 (9.52%)  2/22 (9.09%)  0/6 (0.00%)  0/4 (0.00%) 
Dry mouth  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Dyspepsia  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Gastrooesophageal reflux disease  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Hypoaesthesia oral  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Nausea  1  2/21 (9.52%)  4/22 (18.18%)  2/6 (33.33%)  1/4 (25.00%) 
Stomatitis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Vomiting  1  5/21 (23.81%)  7/22 (31.82%)  1/6 (16.67%)  0/4 (0.00%) 
General disorders         
Catheter site pain  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Catheter site pruritus  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Catheter site related reaction  1  0/21 (0.00%)  0/22 (0.00%)  0/6 (0.00%)  1/4 (25.00%) 
Chest pain  1  0/21 (0.00%)  0/22 (0.00%)  0/6 (0.00%)  1/4 (25.00%) 
Chills  1  2/21 (9.52%)  1/22 (4.55%)  1/6 (16.67%)  0/4 (0.00%) 
Device breakage  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Device leakage  1  0/21 (0.00%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Face oedema  1  0/21 (0.00%)  0/22 (0.00%)  0/6 (0.00%)  1/4 (25.00%) 
Fatigue  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Feeling cold  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Local swelling  1  2/21 (9.52%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Oedema peripheral  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Pain  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  1/4 (25.00%) 
Pyrexia  1  2/21 (9.52%)  1/22 (4.55%)  2/6 (33.33%)  0/4 (0.00%) 
Immune system disorders         
Drug hypersensitivity  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Infections and infestations         
Acute sinusitis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Catheter site infection  1  0/21 (0.00%)  2/22 (9.09%)  0/6 (0.00%)  0/4 (0.00%) 
Cellulitis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Device related infection  1  1/21 (4.76%)  2/22 (9.09%)  0/6 (0.00%)  0/4 (0.00%) 
Infection  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Influenza  1  1/21 (4.76%)  3/22 (13.64%)  1/6 (16.67%)  0/4 (0.00%) 
Nasopharyngitis  1  1/21 (4.76%)  2/22 (9.09%)  0/6 (0.00%)  1/4 (25.00%) 
Oral herpes  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Otitis media acute  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Peritonitis  1  0/21 (0.00%)  0/22 (0.00%)  0/6 (0.00%)  1/4 (25.00%) 
Pharyngitis streptococcal  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Respiratory tract infection  1  1/21 (4.76%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Upper respiratory tract infection  1  4/21 (19.05%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Viral infection  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications         
Arteriovenous fistula site complication  1  2/21 (9.52%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Arthropod bite  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Dialysis related complication  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Femur fracture  1  0/21 (0.00%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Overdose  1  0/21 (0.00%)  0/22 (0.00%)  0/6 (0.00%)  1/4 (25.00%) 
Procedural hypotension  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Procedural nausea  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Vascular graft complication  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Investigations         
Blood calcium abnormal  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Blood phosphorus increased  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  1/4 (25.00%) 
Electrocardiogram T wave abnormal  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Haematocrit decreased  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Haemoglobin decreased  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Haemoglobin increased  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders         
Acidosis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Fluid overload  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Hypercholesterolaemia  1  1/21 (4.76%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Hyperkalaemia  1  3/21 (14.29%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Hyperuricaemia  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Hypoalbuminaemia  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Hypocalcaemia  1  4/21 (19.05%)  5/22 (22.73%)  2/6 (33.33%)  1/4 (25.00%) 
Hypokalaemia  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  1/4 (25.00%) 
Hypomagnesaemia  1  1/21 (4.76%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Hyponatraemia  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Vitamin D deficiency  1  2/21 (9.52%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  2/21 (9.52%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Knee deformity  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Muscle spasms  1  1/21 (4.76%)  3/22 (13.64%)  0/6 (0.00%)  0/4 (0.00%) 
Musculoskeletal pain  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Musculoskeletal stiffness  1  0/21 (0.00%)  2/22 (9.09%)  0/6 (0.00%)  0/4 (0.00%) 
Myalgia  1  1/21 (4.76%)  3/22 (13.64%)  0/6 (0.00%)  0/4 (0.00%) 
Pain in extremity  1  0/21 (0.00%)  1/22 (4.55%)  1/6 (16.67%)  0/4 (0.00%) 
Nervous system disorders         
Convulsion  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Dizziness  1  0/21 (0.00%)  2/22 (9.09%)  0/6 (0.00%)  0/4 (0.00%) 
Epilepsy  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Headache  1  2/21 (9.52%)  3/22 (13.64%)  1/6 (16.67%)  1/4 (25.00%) 
Hypoaesthesia  1  1/21 (4.76%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Paraesthesia  1  1/21 (4.76%)  1/22 (4.55%)  1/6 (16.67%)  1/4 (25.00%) 
Syncope  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Tremor  1  0/21 (0.00%)  3/22 (13.64%)  0/6 (0.00%)  0/4 (0.00%) 
Psychiatric disorders         
Adjustment disorder  1  0/21 (0.00%)  0/22 (0.00%)  0/6 (0.00%)  1/4 (25.00%) 
Anxiety  1  0/21 (0.00%)  2/22 (9.09%)  0/6 (0.00%)  0/4 (0.00%) 
Daydreaming  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Staring  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Renal and urinary disorders         
Hydronephrosis  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Leukocyturia  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/21 (14.29%)  1/22 (4.55%)  1/6 (16.67%)  0/4 (0.00%) 
Dyspnoea  1  0/21 (0.00%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Nasal congestion  1  3/21 (14.29%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Oropharyngeal pain  1  2/21 (9.52%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Rhinorrhoea  1  0/21 (0.00%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Wheezing  1  1/21 (4.76%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders         
Acne  1  0/21 (0.00%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Alopecia  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Dandruff  1  0/21 (0.00%)  0/22 (0.00%)  1/6 (16.67%)  0/4 (0.00%) 
Dermatitis contact  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Hirsutism  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Pruritus  1  1/21 (4.76%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Rash  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Skin irritation  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Swelling face  1  0/21 (0.00%)  1/22 (4.55%)  0/6 (0.00%)  0/4 (0.00%) 
Urticaria  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Vascular disorders         
Haematoma  1  1/21 (4.76%)  0/22 (0.00%)  0/6 (0.00%)  0/4 (0.00%) 
Hypertension  1  4/21 (19.05%)  1/22 (4.55%)  0/6 (0.00%)  1/4 (25.00%) 
Hypotension  1  0/21 (0.00%)  2/22 (9.09%)  0/6 (0.00%)  1/4 (25.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
The study was terminated early with a smaller sample size. However, the study was still sufficiently powered for the double-blind phase. The data collected in the open-label phase is very sparse.
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: NCT01277510     History of Changes
Other Study ID Numbers: 20070208
First Submitted: January 13, 2011
First Posted: January 17, 2011
Results First Submitted: April 29, 2015
Results First Posted: May 15, 2015
Last Update Posted: February 4, 2019