NCT00913393

Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy

A Phase 2 Randomized, Double-blind, Placebo-controlled Study of FG-3019 in Subjects With Type 2 Diabetes Mellitus (DM) and Persistent Proteinuria on Background Angiotensin Converting Enzyme Inhibitor (ACEi) and/or Angiotensin II Receptor Blockade (ARB) Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or diabetic nephropathy.

Detailed description

The primary objective of this study is to assess the effect of FG-3019 on proteinuria as assessed by urinary albumin/creatinine ratio (ACR).

Conditions

• Type 2 Diabetes Mellitus
• Diabetic Nephropathy
• Diabetic Kidney Disease

Interventions

Type	Name	Description
DRUG	FG-3019	3 mg/kg FG-3019 IV every 2 weeks for 22 weeks
DRUG	FG-3019	10 mg/kg FG-3019 IV every 2 weeks for 22 weeks
DRUG	Placebo	Placebo IV every 2 weeks for 22 weeks

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-06-04
• Last updated: 2019-02-22

Locations

28 sites across 1 country: United States