RecruitingPhase 2NCT07494045

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants

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

Sponsor

OPKO Health, Inc.

Enrollment

40 participants

Start Date

Aug 5, 2026

Study Type

INTERVENTIONAL

Conditions

CKD Stage 3 CKD Stage 4 Secondary Hyperparathyroidism VDI

Summary

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.

Eligibility

Min Age: 1 MonthMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CTAP101 for people with ckd stage 3, ckd stage 4, and other related conditions. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.