Renal Anemia Clinical Trial
Official title:
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
| Verified date | November 2007 |
| Source | FibroGen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 145 |
| Est. completion date | July 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Allentown | Pennsylvania |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Chesapeake | Virginia |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Fairfax | Virginia |
| United States | Research Site | Flushing | New York |
| United States | Research Site | Hershey | Pennsylvania |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Kalamazoo | Michigan |
| United States | Research Site | Lauderdale Lakes | Florida |
| United States | Research Site | Little Rock | Arkansas |
| United States | 3 Research Sites | Los Angeles | California |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Oakland | California |
| United States | Research Site | Orangeburg | South Carolina |
| United States | Research Site | Pembroke Pines | Florida |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Pontiac | Michigan |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | Santa Clara | California |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | South Holland | Illinois |
| United States | Research Site | Springfield | Massachusetts |
| United States | Research Site | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| FibroGen |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hemoglobin (Hb) response | |||
| Secondary | Attainment of Hb target range (11-13) | |||
| Secondary | Duration of maintenance of Hb in target range (11-13) | |||
| Secondary | Safety |
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