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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
UCLA - LA BioMed
Los Angeles, California, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Radiant Research
Dallas, Texas, United States
Diabetes & Glandular Disease
San Antonio, Texas, United States
Safety
Tolerability
Pharmacokinetics
Bioactivity on urinary and plasma markers
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University of Virginia
Charlottesville, Virginia, United States