Clinical Trial: Acthar for Treatment of Proteinuria in Membranous Nephropathy Patients
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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
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 Summary:
Sponsor: Mallinckrodt
Current Primary Outcome: Proportion of subjects who have a complete or partial remission in proteinuria [ Time Frame: At Visit 8 (Week 24) ]
Original Primary Outcome: Complete or partial remission in proteinuria [ Time Frame: At Month 6 ]
Current Secondary Outcome:
- Proportion of subjects that have sustained complete or partial remission [ Time Frame: At Visit 8 (Week 24) and Visit 9 (Week 28) ]The subject's response will be considered the average of the two PCR values from the 24-hour urine collections at Visit 8 (Week 24).
- Time to single PCR measured remission (complete or partial) [ Time Frame: At each visit other than Visit 8 (Week 24) ]Single PCR measurements at each visit other than Visit 8 (Week 24) for remission
Original Secondary Outcome: Proportion of subjects that have sustained complete or partial remission [ Time Frame: At Month 6 and Month 7 ]
Information By: Mallinckrodt
Dates:
Date Received: June 29, 2011
Date Started: August 2011
Date Completion:
Last Updated: June 20, 2016
Last Verified: June 2016