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Trial record 81 of 108 for:    CALCIUM CATION

Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01290029
Recruitment Status : Completed
First Posted : February 4, 2011
Results First Posted : December 19, 2016
Last Update Posted : July 16, 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
Secondary Hyperparathyroidism
Intervention Drug: Cinacalcet
Enrollment 14
Recruitment Details The study was conducted at 7 study centers in Belgium (1 site), Germany (1 site), the United Kingdom (2 sites), and the United States (3 sites). The first participant was enrolled 25 January 2011 and the last participant on 25 August 2015.
Pre-assignment Details Due to blood volume collection limitations in children, participants were randomized in a 1:1 ratio to one of the following 2 pharmacodynamic (PD) sampling sequences: 2, 8, and 48 hours postdose; or 2, 12, and 48 hours postdose.
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
Period Title: Overall Study
Started 14
Received Study Treatment 12
Completed 12
Not Completed 2
Reason Not Completed
Other             2
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
All enrolled participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 14 participants
39.5  (17.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
7
  50.0%
Male
7
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Hispanic or Latino
5
  35.7%
Not Hispanic or Latino
7
  50.0%
Unknown or Not Reported
2
  14.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native 0
Asian 2
Black (or African American) 0
Native Hawaiian or Other Pacific Islander 0
White 9
Other 3
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension.
Time Frame Day 1 to day 30
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of cinacalcet.
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description:
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
Any adverse event (AE) 3
Serious adverse events 0
AE leading to discontinuation of study drug 0
Fatal adverse events 0
Treatment-related adverse events 1
Adverse events of interest 1
2.Secondary Outcome
Title Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet
Hide Description [Not Specified]
Time Frame Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics analysis set
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description:
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
11.8  (8.74)
3.Secondary Outcome
Title Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet
Hide Description [Not Specified]
Time Frame Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics analysis set; The AUCinf value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description:
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
11.3  (7.86)
4.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Cinacalcet
Hide Description [Not Specified]
Time Frame Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics analysis set
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description:
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.83  (1.98)
5.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax)
Hide Description [Not Specified]
Time Frame Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics analysis set
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description:
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: hours
1.0
(0.50 to 4.0)
6.Secondary Outcome
Title Terminal Half-life of Cinacalcet
Hide Description The terminal half-life (T1/2) of cinacalcet associated with the slope of the terminal phase.
Time Frame Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics analysis set; The T1/2 value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description:
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: hours
3.70  (2.57)
7.Secondary Outcome
Title Percent Change From Baseline in Intact Parathyroid Hormone
Hide Description [Not Specified]
Time Frame Baseline (predose) and at 2, 8, 12 and 48 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. "n" indicates participants with non-missing data at the time point of interest.
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description:
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: percent change
2 hours post-dose (n = 9)
-10.80
(-18.50 to 23.10)
8 hours post-dose (n = 5)
-29.6
(-42.20 to -12.60)
12 hours post-dose (n = 5)
29.40
(27.70 to 31.20)
48 hours post-dose (n = 9)
-5.40
(-42.30 to 69.00)
8.Secondary Outcome
Title Percent Change From Baseline in Total Calcium
Hide Description [Not Specified]
Time Frame Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. "n" indicates participants with non-missing data at the time point of interest.
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description:
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percent change
2 hours post-dose (n = 11) -4.33  (6.82)
8 hours post-dose (n = 5) -6.38  (5.12)
12 hours post-dose (n = 6) -6.63  (5.05)
48 hours post-dose (n = 8) -4.54  (5.12)
9.Secondary Outcome
Title Percent Change From Baseline in Albumin Corrected Calcium
Hide Description [Not Specified]
Time Frame Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. "n" indicates participants with non-missing data at the time point of interest.
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description:
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percent change
2 hours post-dose (n = 9) -4.01  (7.11)
8 hours post-dose (n = 5) -7.12  (6.71)
12 hours post-dose (n = 5) -4.24  (1.70)
48 hours post-dose (n = 6) -4.10  (5.75)
10.Secondary Outcome
Title Percent Change From Baseline in Ionized Calcium
Hide Description [Not Specified]
Time Frame Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. "n" indicates participants with non-missing data at the time point of interest.
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description:
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percent change
2 hours post-dose (n = 9) -1.77  (3.55)
8 hours post-dose (n = 4) -4.20  (3.83)
12 hours post-dose (n = 4) -4.15  (10.12)
48 hours post-dose (n = 6) -1.45  (4.80)
Time Frame 30 Days
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Cinacalcet 0.25 mg/kg
Hide Arm/Group Description Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
All-Cause Mortality
Cinacalcet 0.25 mg/kg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cinacalcet 0.25 mg/kg
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cinacalcet 0.25 mg/kg
Affected / at Risk (%)
Total   3/12 (25.00%) 
Gastrointestinal disorders   
Vomiting  1  1/12 (8.33%) 
General disorders   
Catheter site haemorrhage  1  1/12 (8.33%) 
Device expulsion  1  1/12 (8.33%) 
Investigations   
Body temperature increased  1  1/12 (8.33%) 
Metabolism and nutrition disorders   
Hypocalcaemia  1  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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: NCT01290029     History of Changes
Other Study ID Numbers: 20090005
First Submitted: January 20, 2011
First Posted: February 4, 2011
Results First Submitted: August 9, 2016
Results First Posted: December 19, 2016
Last Update Posted: July 16, 2019