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
Latest Information Update: 04 Apr 2025
At a glance
- Drugs Calcifediol (Primary)
- Indications Secondary hyperparathyroidism
- Focus Pharmacokinetics; Proof of concept; Therapeutic Use
- Sponsors OPKO Health
- 30 Mar 2025 Status changed from active, no longer recruiting to discontinued.
- 30 Mar 2025 Trial design changed from double blind to single blind. Safety endpoint has been cancelled and PK endpoints are included newly.
- 07 May 2024 According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified May 2022).