Acthar for Treatment of Proteinuria in Membranous Nephropathy Patients
Public ClinicalTrials.gov record NCT01386554. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 Membranous Nephropathy (iMN)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01386554
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2011
- Primary completion
- Nov 20, 2016
- Completion
- May 4, 2017
- Last update posted
- Nov 19, 2019
2011 – 2017
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mallinckrodt Investigational Site | Sacramento | California | 95825 | — |
| Mallinckrodt Investigational Site | Stanford | California | 94304 | — |
| Mallinckrodt Investigational Site | Jacksonville | Florida | 32209 | — |
| Mallinckrodt Investigational Site | Atlanta | Georgia | 30322 | — |
| Mallinckrodt Investigational Site | Rochester | Minnesota | 55905 | — |
| Mallinckrodt Investigational Site | Reno | Nevada | 89502 | — |
| Mallinckrodt Investigational Site | New York | New York | 10032 | — |
| Mallinckrodt Investigational Site | Chapel Hill | North Carolina | 27599 | — |
| Mallinckrodt Investigational Site | Durham | North Carolina | 27705 | — |
| Mallinckrodt Investigational Site | Bethlehem | Pennsylvania | 18017 | — |
| Mallinckrodt Investigational Site | Charleston | South Carolina | 29425 | — |
| Mallinckrodt Investigational Site | Chattanooga | Tennessee | 37404 | — |
| Mallinckrodt Investigational Site | Houston | Texas | 77030 | — |
| Mallinckrodt Investigational Site | Lubbock | Texas | 79430 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01386554, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 19, 2019 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01386554 live on ClinicalTrials.gov.