Primary Focal Segmental Glomerulosclerosis Clinical Trial
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
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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