NCT01386554

Acthar for Treatment of Proteinuria in Membranous Nephropathy Patients

A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of H.P. Acthar Gel (Acthar) in Treatment-Resistant Subjects With Persistent Proteinuria and Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy (iMN)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Proteinuria
• Idiopathic Membranous Nephropathy

Interventions

Type	Name	Description
DRUG	Repository Corticotropin Injection	Acthar given SC for 6 months
DRUG	Placebo	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).

Timeline

• Start date: 2011-08-01
• Primary completion: 2016-11-21
• Completion: 2017-05-05
• First posted: 2011-07-01
• Last updated: 2019-11-20
• Results posted: 2018-03-26

Locations

28 sites across 5 countries: United States, Canada, Chile, Mexico, Turkey (Türkiye)