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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 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.

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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.

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

FieldValue
Enrollment Target 30 participants
Start Date 2024-10-01
Est. Completion 2027-01
Phase Phase 4

Sponsor

NephroNet

2 total trials

What the Registry Record Tells You About NCT07225387

The ClinicalTrials.gov registry entry for NCT07225387 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 309-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (90% lower). The listed sponsor is NephroNet, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 5 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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