drugset / Trial / NCT00754143

Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy

NCT00754143

Phase 1 Completed 38 enrolled Kyntra Bio
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of two dosing regimens of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria on background angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor antagonist (ARB) therapy.

Timeline

Start
2008-03
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pamrevlumab Monoclonal antibody 5 mg/kg Intravenous
Subject Pamrevlumab Monoclonal antibody 10 mg/kg Intravenous