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

NCT00530114 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2016-03-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-11-30
Completion
2009-02-28

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00530114 on ClinicalTrials.gov