Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
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.