NCT05543928Phase 3Terminated

Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-06-19Actual

Enrollment · participants2Actual

Source updated2025-07-25Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Chronic Kidney Disease stage3; Chronic Kidney Disease stage4; Vitamin d Deficiency; Secondary Hyperparathyroidism

Treatments or interventions studied

CTAP101Drug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Numbers of Subjects Who Attained Mean Decrease in Plasma iPTH of 30% From Baseline; description: 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.; timeFrame: 26 weeks; measure: Safety and Tolerability; description: Safety and tolerability will be evaluated in the safety population by AEs, PEs, VS, hematology and laboratory evaluations, and ECGs.; timeFrame: 26 weeks; measure: Pharmacokinetic; description: To assess the pharmacokinetic (PK) profile of 25-hydroxyvitamin D3 after repeated doses of CTAP101 Capsules in pediatric subjects; timeFrame: 26 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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