Conditions: Proteinuria Idiopathic Membranous Nephropathy
Keywords: H.P. Acthar Gel Acthar nephrotic syndrome idiopathic membranous nephropathy proteinuria
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) two times per week arm 2: Placebo (1.0 mL) two times per week arm 3: Acthar (Repository Corticotropin Injection) 40 U (1.0 mL) two times per week

Interventions: intervention 1: Repository Corticotropin Injection intervention 2: Placebo
Intervention descriptions: intervention 1: Acthar given SC for 6 months intervention 2: Placebo contains the same inactive ingredients as that used for H.P. Acthar Gel without the API.

Placebo given SC for 6 months (80 U two times a week).

Protocol document: