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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

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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

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 06 Nov 2021

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At a glance

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

    • Most Recent Events

    • 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.
    • 27 Apr 2016 OPKO resubmitted the NDA following receipt of a complete response letter (CRL) from the FDA on March 29, 2016, in which the FDA indicated the NDA could not be approved due to deficiencies observed during a facility inspection of OPKO's third party manufacturer. A six month review period has been assigned for the resubmitted NDA, and the new Prescription Drug User Fee Act (PDUFA) date will be October 22, 2016.
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