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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

Trial Profile

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: Discontinued
Phase of Trial: Phase II

Latest Information Update: 04 Apr 2025

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At a glance

  • Drugs Calcifediol (Primary)
  • Indications Secondary hyperparathyroidism
  • Focus Pharmacokinetics; Proof of concept; Therapeutic Use
  • Sponsors OPKO Health
  • Most Recent Events

    • 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).

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