A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
Condition(s) studied
Investigational drug(s) / intervention(s)
DMX-200: DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor.
Placebo: Patients will receive 120 mg capsules of Placebo twice daily
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.
Eligibility
Primary outcome measure(s)
- Evaluate the efficacy of DMX-200 in terms of urine protein/creatinine ratio (PCR) in patients with FSGS who are receiving an ARB. — Baseline to Week 35
Percent change in urine PCR (based on 24-hour urine collection) - Evaluate the efficacy of DMX-200 in terms of estimated glomerular filtration rate (eGFR) slope in patients with FSGS who are receiving an ARB (Analysis at week 35 and Week 104). — Baseline to Week 104
Slope of eGFR - OLE - Assess the long-term safety and tolerability of open-label treatment with DMX-200 in patients with FSGS who are receiving an ARB. — Double-blind baseline to Week 216
Incidence and severity of treatment-related adverse events (AEs) and any adverse events of special interest (AESIs) and serious adverse events (SAEs) following long-term treatment with DMX-200.
Trial sites (220)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Active Not Recruiting |
| Phoenix Children's Hospital | Phoenix | Arizona | Recruiting |
| Arizona Kidney Disease and Hypertension Center | Phoenix | Arizona | Active Not Recruiting |
| Loma Linda University Medical Center | Loma Linda | California | Active Not Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | Recruiting |
| University of California, Los Angeles | Los Angeles | California | Recruiting |
| Amicis Research Centre | Northridge | California | Active Not Recruiting |
| Northridge Clinical Research Inc. | Northridge | California | Active Not Recruiting |
| Kaiser Permanente | Oakland | California | Recruiting |
| University of California Davis Health System | Sacramento | California | Recruiting |
| Scripps Health | San Diego | California | Active Not Recruiting |
| Stanford Hospital and Clinic | Stanford | California | Recruiting |
| University of Colorado Anschutz Medical Campus | Denver | Colorado | Recruiting |
| Denver Nephrology Research Division | Denver | Colorado | Recruiting |
| South Florida Nephrology Group, P.A. | Coral Springs | Florida | Active Not Recruiting |
| Nicklaus Children's Hospital | Miami | Florida | Recruiting |
| CTR Oakwater LLC | Orlando | Florida | Recruiting |
| Emory University School of Medicine | Atlanta | Georgia | Recruiting |
| Georgia Nephrology | Lawrenceville | Georgia | Active Not Recruiting |
| Boise Kidney | Boise | Idaho | Active Not Recruiting |
| CARE Institute - Idaho Falls | Idaho Falls | Idaho | Active Not Recruiting |
| University of Chicago | Chicago | Illinois | Active Not Recruiting |
| NorthShore University HealthSystem | Evanston | Illinois | Active Not Recruiting |
| Nephrology Associates of Northern Illinois and Indiana (NANI Research) | Oak Brook | Illinois | Active Not Recruiting |
| University of Louisville | Louisville | Kentucky | Active Not Recruiting |
| The Johns Hopkins Hospital | Baltimore | Maryland | Active Not Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Intermed Consultants | Edina | Minnesota | Active Not Recruiting |
| University of Minnesota | Minneapolis | Minnesota | Recruiting |
| CARE Institute - Nephrology & Hypertension Associates | Tupelo | Mississippi | Active Not Recruiting |
| Children's Mercy Research Institute | Kansas City | Missouri | Recruiting |
| Washington University, School of Medicine | St Louis | Missouri | Recruiting |
| Somnos Clinical Research | Lincoln | Nebraska | Active Not Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Renal Medicine Associates | Albuquerque | New Mexico | Active Not Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | Recruiting |
| University of North Carolina | Chapel Hill | North Carolina | Recruiting |
| Atrium Health | Charlotte | North Carolina | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Active Not Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Active Not Recruiting |
+ 180 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05183646 on ClinicalTrials.gov ↗ ← All trials in Italy