This study is looking at CTAP101 extended-release capsules for children aged 1 month to 17 years who have chronic kidney disease (CKD) stages 3 or 4, secondary hyperparathyroidism, and vitamin D insufficiency. The main goals are to understand how CTAP101 works in the body (pharmacokinetics and pharmacodynamics), and to check its safety and how well participants tolerate it. To join, participants must be 8 to under 18 years old, weigh at least 40 kg, and have been diagnosed with CKD stage 3 or 4 for at least six months, with an eGFR (a measure of kidney function) between 15 and 60 mL/min/1.73m2. The study plans to enroll 40 participants.

Study design

This is an interventional study, meaning participants will receive CTAP101 capsules. The study aims to enroll 40 participants.

What's involved

Participants will take CTAP101 capsules once daily at bedtime for 8 weeks.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for up to 14 weeks to measure how the drug is cleared from the body, its distribution, and how long it stays in the system.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.