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A Randomized, Open-Label, Single-Dose Pilot Study of Oral and i.v. CTAP101 Evaluating PK and Safety in Stage 3 and 4 CKD Subjects With Vitamin D Insufficiency and SHPT

Trial Profile

A Randomized, Open-Label, Single-Dose Pilot Study of Oral and i.v. CTAP101 Evaluating PK and Safety in Stage 3 and 4 CKD Subjects With Vitamin D Insufficiency and SHPT

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Jan 2020

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At a glance

  • Drugs Calcifediol (Primary) ; Calcifediol (Primary)
  • Indications Kidney disorders; Secondary hyperparathyroidism
  • Focus Pharmacokinetics
  • Sponsors Cytochroma
  • Most Recent Events

    • 09 May 2016 According to an OPKO Health media release, data from this (246046) along with other three studies (246052, 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.
    • 24 Jun 2014 New trial record
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