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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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