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NCT05183646 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
A Phase 3 study of FSGS, sponsored by Dimerix Bioscience Pty.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 286
- Enrollment target
- 20
- Study locations
NCT05183646: Recruiting Phase 3 study of FSGS, sponsored by Dimerix Bioscience Pty.
NCT05183646 is a Phase 3 study of FSGS that is actively recruiting participants, run by Dimerix Bioscience Pty. The registered enrollment target is 286 participants, above the 222-participant average among 4 other FSGS trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05183646, a Phase 3 study of FSGS, is actively recruiting participants, sponsored by Dimerix Bioscience Pty.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 286 participants
- Enrollment target
- 20
- Study locations
Study Summary
DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor that, when administered concurrently with an ARB, is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. The purpose of this pivotal randomized double-blind study is to investigate the efficacy and safety of DMX-200 120 mg twice daily (BID) compared with placebo over a treatment period of 104 weeks in adult patients with FSGS who are being treated with an ARB. Given the rarity of the disease and the similarities between adults and pediatric patients with FSGS, Dimerix will also investigate the efficacy and safety of DMX 200 in adolescents aged 12 to 17 years. The double-blind period will be followed by an open-label extension (OLE) which aims to assess the long-term efficacy and safety of DMX 200 for up to 2 additional years.
Primary Outcome
Percent change in urine PCR (based on 24-hour urine collection)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DMX-200
Study Locations (20)
California
- Loma Linda University Medical Center - Loma Linda
- Cedars-Sinai Medical Center - Los Angeles
- University of California, Los Angeles - Los Angeles
- Amicis Research Centre - Northridge
- Northridge Clinical Research Inc. - Northridge
- Kaiser Permanente - Oakland
- University of California Davis Health System - Sacramento
- Scripps Health - San Diego
- Stanford Hospital and Clinic - Stanford
Florida
- South Florida Nephrology Group, P.A. - Coral Springs
- Nicklaus Children's Hospital - Miami
- CTR Oakwater LLC - Orlando
Arizona
- Phoenix Children's Hospital - Phoenix
- Arizona Kidney Disease and Hypertension Center - Phoenix
Colorado
- University of Colorado Anschutz Medical Campus - Denver
- Denver Nephrology Research Division - Denver
Georgia
- Emory University School of Medicine - Atlanta
- Georgia Nephrology - Lawrenceville
Alabama
- University of Alabama at Birmingham - Birmingham
Idaho
- Boise Kidney - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 286 participants |
| Start Date | 2022-05-30 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
What NCT05183646 shows while recruiting
NCT05183646 is an interventional study that assigns participants to a tested intervention. The registered 286 participants enrollment target is mid-sized for trials with a published cap, above the 222-participant average among 4 other FSGS trials with a reported enrollment target (29% higher).
The record links to 1 condition, with FSGS appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05183646 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05183646 about?
NCT05183646 is a clinical study titled "A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB". DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor that, when administered concurrently with an ARB, is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. The purpose of this pivotal randomized double-blind s...
What is the current status of trial NCT05183646?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 286 participants. The study started on 2022-05-30. Estimated completion is 2029-12.
What conditions does trial NCT05183646 study?
This clinical trial studies the following conditions: FSGS.
What interventions are being tested in trial NCT05183646?
The interventions under investigation include: Placebo (DRUG), DMX-200 (DRUG).
Who is sponsoring clinical trial NCT05183646?
This trial is sponsored by Dimerix Bioscience Pty, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05183646 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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