drugset / Trial / NCT02138838
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
Timeline
- Start
- 2014-11-07
- Primary completion
- 2016-06-23
- Completion
- 2016-06-23
Outcome
Missed primary endpoint
Stopped: “Amgen decided to terminate the study early to be able to meet US regulatory timelines fo filing. Subjects in treatment were rolled over to the 20140159 study.”
registry analysis (unspecified test); Standard of Care vs Cinacalcet; p = 0.48; Treatment Difference 8.1 (95% CI -13.7 to 29.9); Cochran-Mantel-Haenszel NCT02138838 ↗
registry analysis (unspecified test); Standard of Care vs Cinacalcet; p = 0.42; Treatment Difference -9.9 (95% CI -33.3 to 13.4); Cochran-Mantel-Haenszel NCT02138838 ↗
Publications
- Background Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.
- 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 | 0.2 mg/kg | Oral |