NCT00754143

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

A Randomized, Double-blind, Placebo-Controlled, Phase 1 Study of Safety, Pharmacokinetics and Pharmacodynamics of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy on Background ACEi and/or ARB Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	FG-3019	Placebo every 2 weeks IV for all infusions
DRUG	FG-3019	FG-3019 5 mg/kg every 2 weeks IV for all infusions
DRUG	FG-3019	FG-3019 10 mg/kg IV for infusions on Days 1, 15, 29 and 57 and Placebo IV on Days 43 and 71

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-09-17
• Last updated: 2019-08-02

Locations

18 sites across 1 country: United States