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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: Completed Phase 4 study, sponsored by Mallinckrodt.
NCT01386554 is a Phase 4 study that has completed, run by Mallinckrodt. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The participant's response was considered the average of the two PCR values from the 24-hour urine collected at Visit 8 (Week 24). Urine protein creatinine ratio (uPCR) was used to assess remission (partial and complete). Complete remission = uPCR \< 0.3 g/g; partial remission = uPCR \< 50% of baseline uPCR and \> 0.3 g/g but \< 3.0 g/g.
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 |
What the finished NCT01386554 record still lists
NCT01386554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01386554 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01386554's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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