Etelcalcetide for children on dialysis with high parathyroid hormone
Part of Hormones & metabolism, Kidney & urinary, Women’s health & pregnancy clinical trials.
This Phase 3 trial tests etelcalcetide to lower a hormone called parathyroid hormone (PTH) in children who have kidney disease and secondary hyperparathyroidism while on hemodialysis. It may help control bone/mineral problems, but the study also checks heart rhythm safety and medication stability.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Be age 2 to under 18 at enrollment (a parent/guardian gives consent; child provides assent if required).
- Be diagnosed with chronic kidney disease and secondary hyperparathyroidism, and be on hemodialysis or hemodiafiltration at least 3 times per week for at least 1 month.
- Have blood test results showing high PTH (two separate lab checks on different days) and a corrected calcium level at or above 9.0 mg/dL.
- Be able to safely continue your dialysis and related medicines: your dialysis “dry weight” at screening must be at least 7 kg, and calcium in the dialysis fluid must be at least 2.5 mEq/L.
- Avoid recent heart-risk issues and certain medicines: no history of congenital long QT or certain dangerous rhythm problems, and no recent use of cinacalcet or etelcalcetide.
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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