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An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

Trial Profile

An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

Recruiting
Phase of Trial: Phase IV

Latest Information Update: 28 Jan 2019

At a glance

  • Drugs Calcifediol (Primary) ; Colecalciferol; Paricalcitol
  • Indications Secondary hyperparathyroidism
  • Focus Adverse reactions
  • Sponsors OPKO Renal
  • Most Recent Events

    • 18 Jan 2019 Planned End Date changed from 4 Dec 2018 to 4 Aug 2019.
    • 18 Jan 2019 Planned primary completion date changed from 4 Nov 2018 to 4 Jun 2019.
    • 23 Jul 2018 New trial record
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