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
Phase 2
Completed
- Conditions
- Renal Anemia
- Registration Number
- NCT00456053
- Lead Sponsor
- FibroGen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Hemoglobin (Hb) response
- Secondary Outcome Measures
Name Time Method Attainment of Hb target range (11-13) Duration of maintenance of Hb in target range (11-13) Safety
Trial Locations
- Locations (2)
Research Site
🇺🇸Fairfax, Virginia, United States
3 Research Sites
🇺🇸Los Angeles, California, United States