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NCT01386554 · ClinicalTrials.gov registry record · Phase 4
Acthar for Treatment of Proteinuria in Membranous Nephropathy Patients
A Phase 4 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT01386554 is a Phase 4 study that has completed, run by Mallinckrodt. The registered enrollment target is 60 participants.
The verdict
NCT01386554, a Phase 4 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Repository Corticotropin Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-08 |
| Est. Completion | 2017-05-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01386554
The ClinicalTrials.gov registry entry for NCT01386554 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01386554 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01386554 about?
NCT01386554 is a clinical study titled "Acthar for Treatment of Proteinuria in Membranous Nephropathy Patients". 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, place...
What is the current status of trial NCT01386554?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2011-08. Estimated completion is 2017-05-05.
What interventions are being tested in trial NCT01386554?
The interventions under investigation include: Placebo (DRUG), Repository Corticotropin Injection (DRUG).
Who is sponsoring clinical trial NCT01386554?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
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