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A Multi-Center Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CTAP101 Extended-release Capsules to Treat Secondary Hyperparathyroidism in Pediatric Subjects of Ages 8 to <18 Years With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

Trial Profile

A Multi-Center Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CTAP101 Extended-release Capsules to Treat Secondary Hyperparathyroidism in Pediatric Subjects of Ages 8 to <18 Years With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 29 Jul 2024

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At a glance

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

    • 25 Jul 2024 Status changed from recruiting to discontinued as FDA changed the post-marketing requirement necessitating a new study design and protocol
    • 22 Feb 2023 Status changed from not yet recruiting to recruiting.
    • 14 Nov 2022 Planned initiation date changed from 1 Oct 2022 to 1 Dec 2022.

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