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
Overview
- Phase
- Phase 2
- Intervention
- Cinacalcet hydrochloride
- Conditions
- Chronic Kidney Disease
- Sponsor
- Amgen
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Hypocalcemia
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cinacalcet
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.
Intervention: Cinacalcet hydrochloride
Cinacalcet
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.
Intervention: Standard of Care
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements(26 weeks)
- Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study(26 weeks)
- Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements(26 weeks)
- Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)(Baseline and weeks 3, 7, 11, 15, 19, 22, and 24)
- Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study(26 weeks)
- Percent Change From Baseline in Corrected Serum Calcium(Baseline and weeks 3, 7, 11, 15, 19, 22, and 24)
- Percent Change From Baseline in Serum Phosphorous(Baseline and weeks 3, 7, 11, 15, 19, 22, and 24)
- Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)(Baseline and weeks 3, 7, 11, 15, 19, 22, and 24)
- Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet(Week 12)
- Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study(26 weeks)
- Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet(Week 12)