Acthar for Treatment of Proteinuria in Membranous Nephropathy Patients
Status:
Completed
Trial end date:
2017-05-05
Target enrollment:
Participant gender:
Summary
The purpose of this study is to provide nephrologists with additional clinical evidence
regarding the efficacy and safety of Acthar in subjects with treatment-resistant idiopathic
membranous nephropathy. Approximately sixty (60) subjects will be randomized in this
double-blind, parallel-group, placebo-controlled, multicenter study comparing Acthar and
Placebo administered 2 times per week for a 24-week treatment period followed by a 24-week
observation period. The primary objective of this study is to assess the proportion of
treatment-resistant subjects (defined as subjects who either have had no response or have
suffered a relapse after achieving a partial response to their most recent standard treatment
regimen) who have a complete or partial remission of proteinuria in nephrotic syndrome due to
idiopathic membranous nephropathy after 24 weeks of treatment.