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RECRUITING

NCT05183646

PHASE3

A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB

Sponsor: Dimerix Bioscience Pty Ltd

View on ClinicalTrials.gov

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.

Official title: A Pivotal Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of DMX-200 in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving an Angiotensin II Receptor Blocker (ARB)

Key Details

Gender

All

Age Range

12 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

286

Start Date

2022-05-30

Completion Date

2029-12

Last Updated

2026-02-03

Healthy Volunteers

Conditions

FSGS

Interventions

DRUG

DMX-200

DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor.

DRUG

Placebo

Patients will receive 120 mg capsules of Placebo twice daily

DOUBLE BLIND PERIOD Inclusion Criteria: 1. Patients must be 12 to 80 years old 2. A diagnosis of primary FSGS, genetic FSGS, or FSGS of undetermined cause. Confirmed by kidney biopsy within 7 years of screening 3. Must be either receiving an ARB at the maximal tolerated dose or willing to transition 4. If taking corticosteroids, the dosage must be stable for ≥4 weeks prior to Screening and during Stabilization 5. If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, or endothelin receptor antagonists (ERAs, including dual antagonists), the dose and regimen must be stable for ≥12 weeks prior to Screening and during Stabilization 6. Urine PCR \>1.5 g/g (\>169.5 mg/mmol) or 24-hour total protein \>1.5 g/day based on 24-hour urine collection during Screening. 7. Estimated eGFR ≥25 and ≤120 mL/min/1.73 m2 at Screening for adults \& eGFR ≥25mL/min/1.73 m2 for adolescent patients (\<18 years) 8. Seated blood pressure ≤160/100 mm Hg (mean of 3 values) (patients ≥18 years of age) or between the 5th and 95th percentile for age, sex, and height (patients \<18 years of age) at Screening 9. Body weight ≥35 kg (all patients) AND a body mass index (BMI) ≤40 kg/m2 (patients ≥18 years of age) or between the 5th and 98th percentile for age and sex (patients \<18 years of age) at Screening. 10. A female patient is eligible to participate if she is not pregnant or planning to become pregnant during the study, not breastfeeding, and at least one of the following conditions applies: 1. Is not of childbearing potential 2. If of childbearing potential and beginning at menarche, agrees to use a highly effective method of contraception consistently during the treatment period. 11. A male patient with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception 12. A patient or parent/legal guardian (as appropriate) who is capable of giving signed informed consent, and where required, the patient is capable of providing assent. Exclusion Criteria: 1. Has FSGS secondary to another condition. 2. Patients with nephrotic syndrome (\>3.5 g/day proteinuria and serum albumin \<30 g/L) who have not previously been treated with standard of care FSGS-directed therapies (including steroids). 3. History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin \[HbA1c\] \>8% at Screening) 4. History of lymphoma, leukemia, or any active malignancy within the past 2 years (except for basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ that have been resected and with no evidence of metastatic disease). 5. Active clinically significant hepatobiliary disease. 6. Documented history of heart failure (New York Heart Association Class III/IV) or a major adverse cardiac event within 12 weeks prior to Screening. 7. Has a physical, medical, or psychological condition, that in the opinion of the Investigator, may interfere with the evaluation the study. 8. The patient has a history of alcohol or illicit drug use disorder within 1 year prior to Screening. 9. Had a prior organ transplant or stem cell transplant, with the exception of corneal transplant. 10. Positive screening assessment for viral hepatitis B surface antigen, or anti-hepatitis C virus (HCV) antibody AND positive HCV RNA, or human immunodeficiency virus 1 and 2. 11. Serum potassium levels \>5.5 mmol/L at Screening. 12. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2 × upper limit of normal (ULN) at Screening. 13. Treatment with non-steroid immunosuppressant agents including biological drugs (e.g. rituximab), calcineurin inhibitors, cyclophosphamide, azathioprine, or mycophenolate mofetil within 12 weeks prior to Screening. 14. History of serious side effects or allergic response to an angiotensin II antagonist or has a known sensitivity to any components in the IP. 15. Unable to swallow oral medication. 16. Prior participation in any Dimerix-sponsored DMX-200 clinical study. 17. Participation in a clinical study with an investigational product (IP) within 28 days or 5 half-lives (whichever is longer) prior to Screening or plans to participate in another study during the course of this study. 18. Are study site personnel directly affiliated with this study and their immediate families OLE PERIOD Inclusion Criteria: 1. A patient or parent/legal guardian (as appropriate) who is capable of giving signed informed consent, and where required, the patient is capable of providing assent. 2. Patients who have completed participation in the double-blind period, including the Week 104 visit, and who may derive benefit from (continued) treatment with DMX-200, and/or continued follow-up 3. The patient received blinded Investigational Product throughout the duration of the double-blind period up to the Week 104 visit 4. The patient continues to meet the contraceptive requirements Exclusion Criteria: 1. The patient has met the criteria for permanent IP discontinuation or study discontinuation 2. Any safety concerns identified during the double-blind period which, in the Investigator's opinion, may interfere with the patient's continued participation during the OLE period.

Locations (220)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

Arizona Kidney Disease and Hypertension Center

Phoenix, Arizona, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, Los Angeles

Los Angeles, California, United States

Amicis Research Centre

Northridge, California, United States

Northridge Clinical Research Inc.

Northridge, California, United States

Kaiser Permanente

Oakland, California, United States

University of California Davis Health System

Sacramento, California, United States

Scripps Health

San Diego, California, United States

Stanford Hospital and Clinic

Stanford, California, United States

University of Colorado Anschutz Medical Campus

Denver, Colorado, United States

Denver Nephrology Research Division

Denver, Colorado, United States

South Florida Nephrology Group, P.A.

Coral Springs, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

CTR Oakwater LLC

Orlando, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Georgia Nephrology

Lawrenceville, Georgia, United States

Boise Kidney

Boise, Idaho, United States

CARE Institute - Idaho Falls

Idaho Falls, Idaho, United States

University of Chicago

Chicago, Illinois, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

Nephrology Associates of Northern Illinois and Indiana (NANI Research)

Oak Brook, Illinois, United States

University of Louisville

Louisville, Kentucky, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Intermed Consultants

Edina, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

CARE Institute - Nephrology & Hypertension Associates

Tupelo, Mississippi, United States

Children's Mercy Research Institute

Kansas City, Missouri, United States

Washington University, School of Medicine

St Louis, Missouri, United States

Somnos Clinical Research

Lincoln, Nebraska, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Renal Medicine Associates

Albuquerque, New Mexico, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Atrium Health

Charlotte, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Kidney and Hypertension Center

Roseburg, Oregon, United States

The Childrens Hospital of Philadelphia Kohls GI Nutrition and Diagnostic Center

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

South Carolina Clinical Research

North Charleston, South Carolina, United States

Carolina Nephrology, PA

Spartanburg, South Carolina, United States

Arlington Nephrology

Arlington, Texas, United States

Nephrotex Research Group

Dallas, Texas, United States

Renal Disease Research Institute, LLC - Dallas

Dallas, Texas, United States

MedResearch, Inc

El Paso, Texas, United States

University Texas Medical Branch

Galveston, Texas, United States

Kaleidoscope Clinical Research

Houston, Texas, United States

Clear Lake Specialties

Webster, Texas, United States

Utah Kidney Research Institute

Salt Lake City, Utah, United States

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Organizacion Medica de Investigacion (OMI)

CABA, Argentina

Centro Médico de Nutrición y Diabetes-CENUDIAB

Ciudad Autonoma Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Hospital General de Agudos Dr. Cosme Argerich

Ciudad Autonoma Buenos Aires, Argentina

Clinica Privada Velez Sarsfield

Córdoba, Argentina

Clinica de Nefrologia Urologia y Enf. Cardiovasculares S.A.

Santa Fe, Argentina

Griffith University

Brisbane, Australia

Princess Alexandra Hospital

Brisbane, Australia

Austin Hospital

Melbourne, Australia

Monash Health

Melbourne, Australia

St Vincent's Hospital Melbourne

Melbourne, Australia

Western Health

Melbourne, Australia

John Hunter Hospital

Sydney, Australia

Liverpool Hospital

Sydney, Australia

Nepean Hospital

Sydney, Australia

Royal North Shore Hospital

Sydney, Australia

UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

Botucatu, Brazil

Hospital das Clínicas da Universidade Federal de Pernambuco

Recife, Brazil

HUPE-UERJ - Hospital Universitário Pedro Ernesto - Universidade Estadual do Rio de Janeiro

Rio de Janeiro, Brazil

Fundação Oswaldo Ramos - Hospital do Rim

São Paulo, Brazil

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, Brazil

The First Affiliated Hospital of Baotou Medical College

Baotou, China

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Peking University First Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

Sichuan Provincial People's Hospital

Chengdu, China

West China Hospital, Sichuan University

Chengdu, China

Guangdong Provincial People's Hospital

Guangzhou, China

The First Affiliated Hospital of Zhejiang University school of medicine

Hangzhou, China

Zhejiang Provincial People's Hospital

Hangzhou, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, China

Shandong Provincial Hospital

Jinan, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Jiangsu Province Hospital

Nanjing, China

Ruijin Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, China

Peking University Shenzhen Hospital

Shenzhen, China

Tianjin Medical University General Hospital

Tianjin, China

General Hospital of Ningxia Medical University

Yinchuan, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, China

Všeobecná fakultní nemocnice v Praze

Prague, Czechia

Rigshospitalet

Copenhagen, Denmark

Kolding Sygehus

Kolding, Denmark

Odense University Hospital

Odense, Denmark

And 120 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (220)