Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
Chronic Kidney Disease
Drug: Cinacalcet hydrochloride
Drug: Standard of Care
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|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|
- Proportion of subjects who develop corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) forages 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for ages ≥ 2 to < 6 years during the study [ Time Frame: 3.5 years ]
- Proportion of subjects who develop corrected serum calcium < 8.8 mg/dL (2.2 mmol/L) during the study [ Time Frame: 3.5 years ]
- PK parameters at week 12 (eg, maximum plasma concentration (Cmax), area under the curve (AUC), apparent clearance (CL/F), apparent volume of distribution (V/F)) [ Time Frame: 3.5 years ]
- The percent change of plasma iPTH, corrected total serum calcium, serum phosphorous, and Ca x P from baseline to scheduled visits during the study [ Time Frame: 3.5 years ]
- Achievement of ≥ 30% reduction from baseline in plasma iPTH during the study [ Time Frame: 3.5 years ]
- Proportion of subjects who have any normal iPTH values between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any two consecutive measurements [ Time Frame: 3.5 years ]
- Achievement of plasma iPTH values < 300 pg/mL (31.8 pmol/L) during the study [ Time Frame: 3.5 years ]
- Proportion of subjects who have any decreases in IPTH of ≥ 30% from baseline at two consecutive measurements [ Time Frame: 3.5 years ]
|Actual Study Start Date:||June 22, 2012|
|Study Completion Date:||June 3, 2016|
|Primary Completion Date:||June 3, 2016 (Final data collection date for primary outcome measure)|
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.
Other Names: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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439867
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