Study of CTAP101 for kids with chronic kidney disease
Part of Hormones & metabolism clinical trials.
This study tests a new extended-release capsule (CTAP101) for children aged 8 to under 18 with moderate to severe chronic kidney disease (CKD). The goal is to see how the drug works in the body, if it's safe, and if it can help control mineral and hormone levels that are often out of balance in CKD.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be 8 to under 18 years old and weigh at least 40 kg (about 88 pounds).
- You must have stage 3 or 4 chronic kidney disease, diagnosed at least 6 months ago, with a certain level of kidney function.
- Your blood tests must show high parathyroid hormone (above 85 pg/mL), low vitamin D (below 30 ng/mL), and calcium and phosphorus levels within specific ranges.
- If you are currently taking certain vitamin D medications (like calcitriol), you must be willing to stop them for the study and complete a 2-week washout.
- You must agree to avoid pregnancy (if applicable) and use effective birth control during the study.
- You must be able to swallow a capsule and follow all study instructions, including coming to all visits.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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