Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Phase 2 Completed 54 enrolled Amgen

RandomizedParallel-groupTriple-blindTreatment

Summary

This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.

Timeline

Start: 2002-06
Primary completion: 2003-03
Completion: 2003-08

Outcome

Met primary endpoint

registry Cinacalcet (AMG 073) vs Placebo; p = 0.006; Odds Ratio (OR) 5.67 (95% CI 1.60 to 20.06); Cochran-Mantel-Haenszel NCT00042432 ↗

paper 56% versus 19% of subjects achieved a 30% or greater reduction in iPTH levels (P = 0.006) PMID 15983958 ↗

Publications

Results Charytan C, Coburn JW, Chonchol M, Herman J, Lien YH, Liu W, Klassen PS, McCary LC, Pichette V. Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis. Am J Kidney Dis. 2005 Jul;46(1):58-67. doi: 10.1053/j.ajkd.2005.04.013.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cinacalcet	Other / unclassified	180 mg	Oral