NCT05543928

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

A Multi-Center Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CTAP101 Extended-release Capsules to Treat Secondary Hyperparathyroidism in Pediatric Subjects of Ages 8 to <18 Years With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.

Conditions

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-01-31
• Primary completion: 2024-06-19
• Completion: 2024-06-19
• First posted: 2022-09-16
• Last updated: 2025-07-25
• Results posted: 2025-07-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study