Trial Outcomes & Findings for Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism (NCT NCT05543928)
NCT ID: NCT05543928
Last Updated: 2025-07-25
Results Overview
The primary efficacy endpoint is the proportion of subjects in the intent-to- treat (ITT) population (age 8 to \<18 years) attaining a mean decrease in plasma iPTH of at least 30% from pre-treatment baseline compared to placebo during the EAP.
TERMINATED
PHASE3
2 participants
26 weeks
2025-07-25
Participant Flow
Participant milestones
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Cohort 1 and Cohort 2 Placebo
Placebo: Placebo
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Cohort 1 and Cohort 2 CTAP101 Capsule
CTAP101: CTAP101 Capsules is an extended-release (ER) oral formulation of calcifediol which was approved as Rayaldee® ER Capsules in June 2016 by the United States (US) Food and Drug Administration (FDA) for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency (VDI), defined as serum total 25-hydroxyvitamin D levels less than 30 ng/mL.
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 26 weeksPopulation: The study was terminated before randomization
The primary efficacy endpoint is the proportion of subjects in the intent-to- treat (ITT) population (age 8 to \<18 years) attaining a mean decrease in plasma iPTH of at least 30% from pre-treatment baseline compared to placebo during the EAP.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 26 weeksPopulation: The study was terminated before randomization
Safety and tolerability will be evaluated in the safety population by AEs, PEs, VS, hematology and laboratory evaluations, and ECGs.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 26 weeksPopulation: The study was terminated before randomization
To assess the pharmacokinetic (PK) profile of 25-hydroxyvitamin D3 after repeated doses of CTAP101 Capsules in pediatric subjects
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 26 weeksPopulation: The study was terminated before randomization
To evaluate the efficacy of repeated dosing with CTAP101 Capsules versus placebo in raising serum total 25-hydroxyvitamin D to ≥30 ng/mL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 26 weeksPopulation: The study was terminated before randomization
To determine the time courses of mean absolute changes from pre-treatment baseline in serum total 25-hydroxyvitamin D and plasma iPTH during administration of repeated doses of CTAP101 Capsules
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 26 weeksPopulation: The study was terminated before randomization
To assess the PD effects of repeated doses of CTAP101 Capsules versus placebo on mean serum calcium (corrected for albumin), serum phosphorus and serum calcium-times-phosphorus (CaxP) product, and the change in mean urine calcium:creatinine ratio
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 26 weeksPopulation: The study was terminated before randomization
To evaluate the safety of CTAP101 Capsules versus placebo with regard to the incidence of hypercalcemia and hyperphosphatemia
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 and Cohort 2 Placebo
Cohort 1 and Cohort 2 CTAP101 Capsule
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place