A Randomized, Double Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects With Chronic Kidney Disease, Vitamin D Insufficiency and Secondary Hyperparathyroidism

Trial Profile

A Randomized, Double Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects With Chronic Kidney Disease, Vitamin D Insufficiency and Secondary Hyperparathyroidism

Completed
Phase of Trial: Phase II/III

Latest Information Update: 30 Aug 2016

At a glance

  • Drugs Calcifediol (Primary)
  • Indications Secondary hyperparathyroidism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Cytochroma
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 09 May 2016 According to an OPKO Health media release, Primary endpoints (To determine efficacy of repeat dose CTAP101 Capsules in reducing plasma intact parathyroid hormone.) and (To determine the efficacy of repeat doses of study drug compared to placebo in increasing serum vitamin D levels.) have been met.
    • 09 May 2016 According to an OPKO Health media release, data from this (246052) along with other three studies (246046, 238771 & 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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