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

FibroGen

Status and phase: Completed; Phase 2

Conditions: Renal Anemia

Treatments: Drug: FG2216

Study type: Interventional

Funder types: Industry

Identifiers

NCT00456053

FGCL-SM2216-019

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind