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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of CTAP101 Capsules to Treat Secondary Hyperparathyroidism in Subjects With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

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Trial Profile

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of CTAP101 Capsules to Treat Secondary Hyperparathyroidism in Subjects With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jan 2023

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At a glance

  • Drugs Calcifediol (Primary)
  • Indications Secondary hyperparathyroidism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Cytochroma; OPKO Health

    • Most Recent Events

    • 17 Nov 2016 According to an OPKO Health media release, pooled data from this and another phase III study (profile 238767) are being presented in a poster presentation at the American Society of Nephrology Kidney Week Meeting.
    • 21 Jun 2016 According to an OPKO Health media release, the US FDA has approved RAYALDEE (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. The approval was based on two phase III trials (700238767 and 238771) and an open-label extension study (700238773).
    • 09 May 2016 According to an OPKO Health media release, data from this (238771) along with other three studies (246052, 246046 & 238767) supported the New Drug Application (NDA) for CTAP101 for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

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