NCT01665391

A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)

A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this trial are as follows: * to compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo * to compare the safety profile of patients treated with fresolimumab versus placebo The secondary objectives are as follows: * To compare the reduction in proteinuria in patients treated with fresolimumab versus placebo * To evaluate fresolimumab dose-dependent reduction in proteinuria * To compare the change in renal function (estimated glomerular filtration rate \[eGFR\]) in patients treated with fresolimumab versus placebo * To evaluate the multiple-dose pharmacokinetics of fresolimumab

Conditions

• Primary Focal Segmental Glomerulosclerosis

Interventions

Type	Name	Description
DRUG	fresolimumab	1 mg/kg total body weight administered intravenous (IV)
DRUG	fresolimumab	4 mg/kg total body weight administered intravenous (IV)
DRUG	Placebo	Placebo administered to match active treatment group

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-06-01
• Completion: 2014-11-01
• First posted: 2012-08-15
• Last updated: 2015-08-26

Locations

32 sites across 5 countries: United States, Brazil, Germany, Italy, Spain