Status: Not yet recruiting
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
The goal of this clinical trial is to evaluate safety, tolerability, and how CTAP101 Capsules work to treat Pediatric Participants with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency. The main questions it aims to answer are: 1. To assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of CTAP101 Capsules 2. To investigate the safety and tolerability of CTAP101 Capsules Participants will take a daily dosage of CTAP101 Capsules at bedtime for 8 weeks.
Participants needed: 40
Trial details
Phase: Phase 2Age: 1-17Biological sex: AllType: InterventionalSponsor: OPKO Health, Inc.Updated: Mar 30, 2026Locations: 5
Eligibility criteria
Be 8 to <18 years of age with a body weight of ≥40 kg. [+16]
Kidney transplant within the 26 weeks preceding screening or kidney transplant r... [+8]