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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

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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: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 07 May 2024

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At a glance

  • Drugs Calcifediol (Primary)
  • Indications Secondary hyperparathyroidism
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Proof of concept; Therapeutic Use
  • Sponsors OPKO Health

    • Most Recent Events

    • 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).
    • 04 Mar 2021 Planned End Date changed from 15 Feb 2021 to 31 Mar 2023.
    • 04 Mar 2021 Planned primary completion date changed from 31 Dec 2020 to 31 Mar 2023.

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