Study Complete
Sponsor ID
20070664

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

Sponsor ID
20070664
Clinicaltrials.gov ID
NCT00530114
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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

Additional Study Details

Phase
Phase 2
Product
bixalomer
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
167
Additional Study Details

Protocol Summary

Primary Outcome Measures

To demonstrate the 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

Timeframe: TREATMENT PERIOD

Secondary Outcome Measures

To describe a dose response for AMG 223

Timeframe: TREATMENT PERIOD

To evaluate the safety and tolerability of AMG 223

Timeframe: ENTIRE STUDY

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.