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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FibroGen
• Treatments: Epoetin Alfa

Criteria

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