drugset / Trial / NCT00530114

Study to Assess Fixed Dosing of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia

NCT00530114

Phase 2 Completed 167 enrolled Amgen
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objectives of this study are the following: 1. To demonstrate that AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis 2. To describe a dose response for AMG 223 3. To evaluate the safety and tolerability of AMG 223

Timeline

Start
2008-03
Primary completion
2008-11
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bixalomer Small molecule 1 g Oral
Subject Bixalomer Small molecule 3 g Oral
Subject Bixalomer Small molecule 4 g Oral
Subject Bixalomer Small molecule 5 g Oral