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NCT07225387 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial
A Phase 4 study of Lupus Nephritis, sponsored by NephroNet.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 7
- Study locations
NCT07225387: Recruiting Phase 4 study of Lupus Nephritis, sponsored by NephroNet.
NCT07225387 is a Phase 4 study of Lupus Nephritis that is actively recruiting participants, run by NephroNet. The registered enrollment target is 30 participants, below the 309-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (90% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07225387, a Phase 4 study of Lupus Nephritis, is actively recruiting participants, sponsored by NephroNet.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a Phase IV, open-label, randomized trial to determine whether the combination of Belimumab (BEL) and Voclosporin (VCS), plus background therapy with Mycophenolate Mofetil (MMF), improves the proportion of patients with proliferative lupus nephritis achieving complete renal response (CRR) compared to proportion of patients achieving CRR from recent clinical trials. This protocol will additionally determine whether combination therapy using Belimumab (BEL) and Voclosporin (VCS) facilitates rapid discontinuation of MMF.
Primary Outcome
Proportion of Patients achieving and maintaining a Complete Clinical Renal Remission (CCRR) at 12 months. CCRR is defined as: UPCR≤ 0.5, eGFR≥60 and not \>20% below baseline, no rescue meds, sustained on repeat assessment 30 days later.
Conditions Studied
Interventions
- DRUG Voclosporin
Study Locations (7)
Georgia
- Piedmont Physicians Rheumatology - Atlanta
- Georgia Nephrology Research Institute - Lawrenceville
- Parris & Associates - Lawrenceville
Arizona
- AARA Clinical Research - Glendale
Ohio
- Nephrology Clinical Trials Unit The Ohio State University Wexner Medical Center - Columbus
Oklahoma
- Oklahoma Medical Research Foundation - Oklahoma City
Texas
- AARA Clinical Research - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2027-01 |
| Phase | Phase 4 |
What NCT07225387 shows while recruiting
NCT07225387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 309-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 1 intervention - of which Voclosporin is the first listed.
NCT07225387 lists 7 locations in 5 states (Georgia, Arizona, Ohio).
Frequently Asked Questions
What is clinical trial NCT07225387 about?
NCT07225387 is a clinical study titled "Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial". This is a Phase IV, open-label, randomized trial to determine whether the combination of Belimumab (BEL) and Voclosporin (VCS), plus background therapy with Mycophenolate Mofetil (MMF), improves the proportion of patients with proliferative lupus nephritis achieving complete renal response (CRR) com...
What is the current status of trial NCT07225387?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2024-10-01. Estimated completion is 2027-01.
What conditions does trial NCT07225387 study?
This clinical trial studies the following conditions: Lupus Nephritis.
What interventions are being tested in trial NCT07225387?
The interventions under investigation include: Voclosporin (DRUG).
Who is sponsoring clinical trial NCT07225387?
This trial is sponsored by NephroNet, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07225387 being conducted?
This trial has 7 study locations across Arizona, Georgia, Ohio, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07225387's enrollment target sits among peer trials
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