MedTrace Logo

A Phase 1 Multiple Dose Study to Compare the Effects of AMG 223 and Sevelamer HCL (Renagel®)

NCT00756860 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2012-06-04

No results posted yet for this study

Summary

The purpose of this study is to determine if subjects on 2g AMG 223 will achieve 60% or greater reduction in urinary phosphorus from baseline compared to subjects on 2g Renagel®.

Renagel®, Sevelamer HCl is currently the market leader for the treatment of hyperphosphatemia in patients on dialysis.

Conditions

  • Healthy Volunteers

Interventions

DRUG

AMG 223

2 g AMG 223 (4 x 500 mg capsules ) TID on Days 1 through 7

DRUG

Renagel® (sevelamer hydrochloride)

2g Renagel® (2 x 800 mg capsules + 1 x 400 mg capsule) TID on Days 1 through 7

Sponsors & Collaborators

  • Amgen Research (Munich) GmbH

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-08-31
Completion
2009-09-30

More Related Trials

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 NCT00756860 on ClinicalTrials.gov