drugset / Trial / NCT01101113

Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level

NCT01101113 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT) and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.

Timeline

Start
2010-09
Primary completion
2012-03
Completion
2012-06

Outcome

Missed primary endpoint

paper The proportion of patients who reached the primary endpoint was not statistically different (48.5% vs. 51.5%, cinacalcet vs. control, P = 1.000). PMID 23705925 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cinacalcet Other / unclassified 25 mg —
Subject Cinacalcet Other / unclassified 50 mg —