NCT00530114

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

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Fixed Dose Study of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• End Stage Renal Disease
• Chronic Kidney Disease
• Hyperphosphatemic
• Kidney Disease

Interventions

Type	Name	Description
DRUG	AMG 223	1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
DRUG	Placebo	1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-11-01
• Completion: 2009-02-01
• First posted: 2007-09-17
• Last updated: 2016-03-14