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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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