A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
NCT ID: NCT05183646
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
286 participants
INTERVENTIONAL
2022-05-30
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DMX-200 (repagermanium)
Patients will receive 120 mg immediate release capsules of DMX-200 twice daily during the treatment period (104 weeks)
OLE: Patients will receive 120 mg immediate release capsules of DMX-200 twice daily during the OLE period (108-212 weeks)
DMX-200
DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor.
Placebo
Patients will receive 120 mg immediate release capsules of Placebo twice daily
Placebo
Patients will receive 120 mg capsules of Placebo twice daily
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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
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
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.
12 Years
80 Years
ALL
No
Sponsors
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Dimerix Bioscience Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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David Fuller
Role: STUDY_DIRECTOR
Dimerix Bioscience Pty Ltd
Locations
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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
Groupe Hospitalier Pellegrin
Bordeaux, Gironde, France
Hôpital Henri Mondor
Créteil, , France
CHU de Grenoble Hopital Nord
Grenoble, , France
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, , France
Hopital de la Conception APHM
Marseille, , France
Hopital Lapeyronie pt
Montpellier, , France
Hôpital Necker Enfants Malades
Paris, , France
CHU Saint Etienne Hôpital Nord
Saint-Priest-en-Jarez, , France
Universitaetsklinikum Aachen AOeR
Aachen, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Zentrum fuer Nieren Hochdruck und Stoffwechselerkrankungen
Hanover, , Germany
Universitaetsklinikum Schleswig Holstein - Campus Luebeck
Lübeck, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, , Germany
Nephrologischen Zentrum Villingen-Schwenningen
Villingen-Schwenningen, , Germany
Pok Oi Hospital
Hong Kong, , Hong Kong
Princess Margaret Hospital
Hong Kong, , Hong Kong
The University of Hong Kong
Hong Kong, , Hong Kong
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, , Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, , Italy
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Ospedale San Raffaele
Milan, , Italy
Fondazione Salvatore Maugeri IRCCS
Pavia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Ospedale San Giovanni Bosco
Torino, , Italy
Kasugai Municipal Hospital
Kasugai, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
Teikyo University Chiba Medical Center
Ichihara, Chiba, Japan
Kyushu University Hospital
Higashi, Fukuoka, Japan
Yokohama City University Hospital
Yokohama, Fukuura, Japan
Asahikawa Red Cross Hospital
Asahikawa, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Okayama University Hospital
Kitaku, Okayama-ken, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Tokushima University Hospital
Tokushima, Tokushima, Japan
Nagoya University Hospital
Shōwaku, Tsurumaicho, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
NHO Chibahigashi National Hospital
Chiba, , Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Tokyo Women's Medical University Hospital
Tokyo, , Japan
Hospital Serdang
Kajang, Selangor, Malaysia
Pusat Perubatan Universiti Kebangsaan Malaysia
Cheras, , Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, , Malaysia
Sunway Medical Centre
Petaling Jaya, , Malaysia
Centenario Hospital Miguel Hidalgo
Aguascalientes, , Mexico
Servicios Hospitalarios De Mexico S A De C V
Chihuahua City, , Mexico
Neurociencias Estudios Clinicos
Culiacán, , Mexico
Hospital Civil Fray Antonio Alcalde
Guadalajara, , Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, , Mexico
Auckland City Hospital
Auckland, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Centro Clinico Academico Braga, Associação (2CA-Braga)
Braga, , Portugal
Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
Carnaxide, , Portugal
Centro Hospitalar Universitario Lisboa Central E.P.E. Hospital Curry Cabral
Lisbon, , Portugal
Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital de Santa Maria
Lisbon, , Portugal
Hospital de Loures, E.P.E.
Loures, , Portugal
Unidade Local de Saúde de São João, E.P.E
Porto, , Portugal
Centro Hospitalar de Setúbal, E.P.E., Hospital de São Bernardo
Setúbal, , Portugal
Unidade Local de Saude do Estuario Tejo E.P.E., Hospital Vila Franca de Xira
Vila Franca de Xira, , Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Vila Nova de Gaia, , Portugal
Torrecárdenas University Hospital
Almería, , Spain
Fundacion Puigvert
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Shuangho Hospital Ministry of Health and Welfare
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Phramongkutklao Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkoknoi, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Songklanagarind Hospital
Hat Yai, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
King Chulalongkorn Memorial Hospital
Pathum Wan, , Thailand
Ankara Training and Research Hospital
Ankara, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Akdeniz University Faculty of Medicine
Antalya, , Turkey (Türkiye)
Uludag University Medical Faculty
Bursa, , Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, , Turkey (Türkiye)
Erciyes University Medical Faculty
Erciyes, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Kocaeli University Research and Application Hospital
Kocaeli, , Turkey (Türkiye)
Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Kent and Canterbury Hospital
Canterbury, , United Kingdom
St. Helier Hospital
Carshalton, , United Kingdom
University Hospital Coventry & Warwickshire
Coventry, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
Great Ormond Street Hospital for Children
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Royal Berkshire Hospital
Manchester, , United Kingdom
Royal Manchester Childrens Hospital
Manchester, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Salford Care Organisation
Salford, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
Lister Hospital
Stevenage, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2023-504597-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DMX-200-301
Identifier Type: -
Identifier Source: org_study_id
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