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.
Phase of Trial: Phase II
Latest Information Update: 04 Sep 2018
At a glance
- Drugs Calcifediol (Primary)
- Indications Secondary hyperparathyroidism
- Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Therapeutic Use
- 04 Sep 2018 According to an OPKO Health media release, The first cohort of approximately 44 patients will be treated for 26 weeks in a randomized, open-label fashion with either RAYALDEE or placebo to identify the appropriate dosing to be studied in the second cohort. Data readout for this first cohort is expected in 2019.
- 25 Jul 2018 Status changed from planning to recruiting.
- 08 May 2018 According to an OPKO Health media release, the company anticipates initiating this trial during the 3Q 2018.