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Clinical trial

An Open-Label, Randomized, Multiple-Dose, Multi-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of CTAP101 Extended-release Capsules in Pediatric Participants <18 Years of Age With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

NCT07494045 is registered in ClinicalTrials.gov with OPKO Health, Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
An Open-Label, Randomized, Multiple-Dose, Multi-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of CTAP101 Extended-release Capsules in Pediatric Participants <18 Years of Age With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
Lead sponsor
OPKO Health, Inc.
Phase
Phase 2
Overall status
Recruiting
Start date
August 5, 2026
Completion date
August 31, 2028
Enrollment
40 (estimated)
Sites
5

Conditions

As the registry lists them; a condition with its own page is linked.

ckd stage 3, ckd stage 4, secondary hyperparathyroidism, vdi