NCT03602261

Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI

A Multi-Center, Randomized, Two-Cohort Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of CTAP101 (Calcifediol) Extended-Release Capsules to Treat Secondary Hyperparathyroidism in Subjects With Vitamin D Insufficiency and Chronic Kidney Disease Requiring Regular Hemodialysis.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI

Detailed description

A Multi-Center, Randomized, Two-Cohort Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of CTAP101 (calcifediol) Extended-Release Capsules to Treat Secondary Hyperparathyroidism (SHPT) in Subjects with Vitamin D Insufficiency (VDI) and Chronic Kidney Disease Requiring Regular Hemodialysis.

Conditions

• Secondary Hyperparathyroidism Due to Renal Causes
• Chronic Kidney Diseases
• Vitamin D Deficiency
• Stage 5 Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Calcifediol Oral Capsule	Capsule, weekly
DRUG	Placebo oral capsule	Capsule, weekly

Timeline

• Start date: 2018-07-09
• Primary completion: 2021-02-24
• Completion: 2021-02-24
• First posted: 2018-07-26
• Last updated: 2026-04-03
• Results posted: 2025-03-30

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study