Status:

COMPLETED

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

Lead Sponsor:

FibroGen

Conditions:

Renal Anemia

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

December 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2007

Estimated Enrollment :

145 Patients enrolled

Trial Details

Trial ID

NCT00456053

Start Date

December 1 2005

End Date

July 1 2007

Last Update

November 6 2007

Active Locations (27)

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Page 1 of 7 (27 locations)

1

Research Site

Tucson, Arizona, United States

2

Research Site

Little Rock, Arkansas, United States

3

3 Research Sites

Los Angeles, California, United States

4

Research Site

Oakland, California, United States

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 | DecenTrialz