drugset / Trial / NCT01277510
Pediatric Chronic Kidney Disease Safety and Efficacy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.
Timeline
- Start
- 2011-06-28
- Primary completion
- 2014-04-30
- Completion
- —
Outcome
Met primary endpoint
Stopped: “Study was put on clinical hold on 30 Jan 2013 following a subject fatality. Study was never restarted and was closed.”
registry analysis (unspecified test); Placebo vs Cinacalcet; p = 0.017; Difference (Cinacalcet - Placebo) 35.50 (95% CI 8.76 to 62.24); Cochran-Mantel-Haenszel NCT01277510 ↗
Publications
- Background Warady BA, Iles JN, Ariceta G, Dehmel B, Hidalgo G, Jiang X, Laskin B, Shahinfar S, Vande Walle J, Schaefer F. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet in pediatric patients with chronic kidney disease and secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2019 Mar;34(3):475-486. doi: 10.1007/s00467-018-4116-y. Epub 2018 Nov 30.
- Background Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cinacalcet | Other / unclassified | 4.2 mg/kg | Oral |