Spots Global Cancer Trial Database for Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
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Trial Identification
Brief Title: Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
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
Study ID: NCT05543928
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 8 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Nationwide Childrens Hospital, Columbus, Ohio, United States
Contact Details
Name: Akhtar Ashfaq, MD
Affiliation: OPKO Health
Role: STUDY_DIRECTOR
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