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Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism

Vitamin d Deficiency Clinical Trial

Official title:
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

Clinical Trial Summary

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05543928
Study type Interventional
Source OPKO Health, Inc.
Contact Christina Gomes
Phone 747-888-3011
Email cgomes@opko.com
Status Recruiting
Phase Phase 3
Start date January 31, 2023
Completion date July 2025
View Details
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