Clinical trial
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.
NCT03602261 is registered in ClinicalTrials.gov with OPKO Health, Inc. as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- 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.
- Lead sponsor
- OPKO Health, Inc.
- Phase
- Phase 2
- Overall status
- Terminated
- Start date
- July 9, 2018
- Completion date
- February 24, 2021
- Enrollment
- 44 (actual)
- Sites
- 18
Conditions
As the registry lists them; a condition with its own page is linked.
chronic kidney diseases, secondary hyperparathyroidism due to renal causes, stage 5 chronic kidney disease, vitamin d deficiency