Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus

Summary

The Phase 1b study is a multi-center trial designed to test the safety, tolerability, biologic activity of escalating doses of FG-3019 in up to 20 patients with type 1 or type 2 diabetes and microalbuminuria (early-stage kidney disease). Patients will receive either 3 or 10 mg/kg of FG-3019 administered every two weeks as an infusion for a total of four doses. The ability of FG-3019 to reduce the excretion of protein in the urine is being measured as a secondary endpoint.

Timeline

Start

2005-01

Primary completion

—

Completion

2007-06

Drugs

Indications