drugset / Trial / NCT00527085

12-month Study of AMG 073 in Renal Osteodystrophy

NCT00527085

Phase 2 Completed 45 enrolled Amgen
RandomizedParallel-groupTriple-blindTreatment

Summary

4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.

Timeline

Start
2001-10
Primary completion
2003-08
Completion
2003-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cinacalcet Other / unclassified 30 mg Oral
Subject Cinacalcet Other / unclassified 50 mg Oral
Subject Cinacalcet Other / unclassified 70 mg Oral
Subject Cinacalcet Other / unclassified 90 mg Oral
Subject Cinacalcet Other / unclassified 120 mg Oral
Subject Cinacalcet Other / unclassified 180 mg Oral

Indications