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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Hyperparathyroidism, Secondary||Drug: Cinacalcet hydrochloride Drug: Standard of Care||Phase 2|
This is a multicenter, 26-week, single-arm, open-label, safety study. Participants were to remain on study for 26 weeks or until time of kidney transplantation, whichever came first.
The study and enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes.
Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis|
|Actual Study Start Date :||June 22, 2012|
|Actual Primary Completion Date :||June 3, 2016|
|Actual Study Completion Date :||June 3, 2016|
Prior to the partial clinical hold, the starting dose was 0.25 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 4.2 mg/kg) based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms.
After the partial clinical hold the starting dose was 0.20 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 2.5 or 60 mg, whichever was lower) based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms.
All participants also received standard of care, which may have included vitamin D sterols.
Drug: Cinacalcet hydrochloride
Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily.
Drug: Standard of Care
Standard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator.
- Percentage of Participants With Hypocalcemia [ Time Frame: 26 weeks ]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.
- Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study [ Time Frame: 26 weeks ]
- Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) [ Time Frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24 ]
- Percent Change From Baseline in Corrected Serum Calcium [ Time Frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24 ]
- Percent Change From Baseline in Serum Phosphorous [ Time Frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24 ]
- Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) [ Time Frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24 ]
- Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements [ Time Frame: 26 weeks ]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.
- Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study [ Time Frame: 26 weeks ]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.
- Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements [ Time Frame: 26 weeks ]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.
- Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study [ Time Frame: 26 weeks ]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.
- Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet [ Time Frame: Week 12 ]
- Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet [ Time Frame: Week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439867
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