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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Nov 2016

At a glance

  • Drugs Calcifediol (Primary)
  • Indications Hyperparathyroidism; Renal failure; Secondary hyperparathyroidism; Vitamin D deficiency
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors OPKO Health
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 17 Nov 2016 According to an OPKO Health media release, pooled data from this and another phase III study (profile 238771) 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).
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top