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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

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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

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 13 Dec 2022

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At a glance

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

Most Recent Events

  • 30 Jul 2020 Status changed from recruiting to completed.
  • 25 Mar 2020 According to an OPKO Health Media Release, Final results from this trial are expected in the second half of 2020.
  • 25 Mar 2020 According to an OPKO Health Media Release, To date, 67 subjects have been enrolled and 62 have completed treatment.Enrollment is expected to be completed by the end of the second quarter of this year.

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