A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin

NCT ID: NCT00456053

Last Updated: 2007-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-07-31

Brief Summary

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The purpose of this study is to test the safety and efficacy of FG-2216 in the treatment of patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.

Detailed Description

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Conditions

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Renal Anemia

Keywords

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Renal Anemia Renal Failure Kidney Disease Human EPO

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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FG2216

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stage 3 or 4 chronic kidney disease
* appropriate hemoglobin levels

Exclusion Criteria

* Neovascular age related macular degeneration requiring treatment
* Macular edema or proliferative retinopathy in diabetic subjects, requiring treatment
* Any history of malignancy
* Therapy with recombinant erythropoietin or red blood cell transfusion within 4 weeks
* Renal Transplant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FibroGen

INDUSTRY

Sponsor Role lead

Locations

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Research Site

Tucson, Arizona, United States

Site Status

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Little Rock, Arkansas, United States

Site Status

3 Research Sites

Los Angeles, California, United States

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Oakland, California, United States

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San Diego, California, United States

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Santa Clara, California, United States

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Lauderdale Lakes, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Atlanta, Georgia, United States

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South Holland, Illinois, United States

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Shreveport, Louisiana, United States

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Springfield, Massachusetts, United States

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Kalamazoo, Michigan, United States

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Pontiac, Michigan, United States

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Flushing, New York, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Orangeburg, South Carolina, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Chesapeake, Virginia, United States

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Fairfax, Virginia, United States

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Countries

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United States

Other Identifiers

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FGCL-SM2216-019

Identifier Type: -

Identifier Source: org_study_id