A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB (ACTION3)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: FSGS
• Intervention / Treatment: Drug: DMX-200; Drug: Placebo

Detailed Description

This is a pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS. The duration of the double-blind period per patient is estimated to be maximum of 122 weeks, a Screening and Qualification period of between 6 and 14 weeks (including a 4 week period to complete the assessments required for Screening, Titration (if required, up to 4 weeks) and, 6-weeks of Stabilization, a 104-week Treatment period, and up to a 4-week off-treatment Follow-up period. The treatment duration of the OLE period per patient is estimated to be a minimum of 104 weeks (2 years) with a 4-week off-treatment Follow-up period. The total study duration (double-blind period and OLE combined) is currently estimated to be a minimum of 230 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 286
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: David Fuller; Phone Number: +61 1300 813 321; Email: ACTION3@dimerix.com
• Study Contact Backup: Name: Alisha Smith; Phone Number: +61 1300 813 321; Email: ACTION3@dimerix.com

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Recruiting
    • Hospital Italiano de Buenos Aires
  • Buenos Aires, Argentina
    • Active, not recruiting
    • Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
  • CABA, Argentina
    • Active, not recruiting
    • Organización Médica de Investigación (OMI)
  • Ciudad Autonoma Buenos Aires, Argentina
    • Active, not recruiting
    • Centro Médico de Nutrición y Diabetes-CENUDIAB
  • Ciudad Autonoma Buenos Aires, Argentina
    • Active, not recruiting
    • Hospital Britanico de Buenos Aires
  • Ciudad Autonoma Buenos Aires, Argentina
    • Active, not recruiting
    • Hospital General de Agudos Dr. Cosme Argerich
  • Córdoba, Argentina
    • Active, not recruiting
    • Clinica Privada Velez Sarsfield
  • Santa Fe, Argentina
    • Recruiting
    • Clinica de Nefrologia Urologia y Enf. Cardiovasculares S.A.
• Australia
  • Brisbane, Australia
    • Active, not recruiting
    • Griffith University
  • Brisbane, Australia
    • Active, not recruiting
    • Princess Alexandra Hospital
  • Melbourne, Australia
    • Active, not recruiting
    • Austin Hospital
  • Melbourne, Australia
    • Active, not recruiting
    • Monash Health
  • Melbourne, Australia
    • Active, not recruiting
    • St Vincent's Hospital Melbourne
  • Melbourne, Australia
    • Active, not recruiting
    • Western Health
  • Sydney, Australia
    • Active, not recruiting
    • Royal North Shore Hospital
  • Sydney, Australia
    • Active, not recruiting
    • John Hunter Hospital
  • Sydney, Australia
    • Active, not recruiting
    • Liverpool Hospital
  • Sydney, Australia
    • Active, not recruiting
    • Nepean Hospital
• Brazil
  • Botucatu, Brazil
    • Active, not recruiting
    • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
  • Recife, Brazil
    • Active, not recruiting
    • Hospital das Clínicas da Universidade Federal de Pernambuco
  • Rio de Janeiro, Brazil
    • Active, not recruiting
    • HUPE-UERJ - Hospital Universitário Pedro Ernesto - Universidade Estadual do Rio de Janeiro
  • São Paulo, Brazil
    • Active, not recruiting
    • Fundação Oswaldo Ramos - Hospital do Rim
  • São Paulo, Brazil
    • Active, not recruiting
    • Hospital das Clinicas da Faculdade de Medicina da USP
• China
  • Baotou, China
    • Active, not recruiting
    • The First Affiliated Hospital of Baotou Medical College
  • Beijing, China
    • Active, not recruiting
    • Peking University First Hospital
  • Beijing, China
    • Active, not recruiting
    • Beijing Anzhen Hospital, Capital Medical University
  • Beijing, China
    • Active, not recruiting
    • Beijing Tongren Hospital, Capital Medical University
  • Beijing, China
    • Active, not recruiting
    • Peking University People's Hospital
  • Chengdu, China
    • Active, not recruiting
    • Sichuan Provincial People's Hospital
  • Chengdu, China
    • Active, not recruiting
    • West China Hospital, Sichuan University
  • Guangzhou, China
    • Active, not recruiting
    • Guangdong Provincial People's Hospital
  • Hangzhou, China
    • Active, not recruiting
    • Zhejiang Provincial People's Hospital
  • Hangzhou, China
    • Active, not recruiting
    • The First Affiliated Hospital of Zhejiang University School of Medicine
  • Hohhot, China
    • Active, not recruiting
    • The Affiliated Hospital of Inner Mongolia Medical University
  • Jinan, China
    • Active, not recruiting
    • Shandong Provincial Hospital
  • Nanchang, China
    • Active, not recruiting
    • The First Affiliated Hospital of Nanchang University
  • Nanjing, China
    • Active, not recruiting
    • Jiangsu Province Hospital
  • Shanghai, China
    • Active, not recruiting
    • Ruijin Hospital of Shanghai Jiaotong University School of Medicine
  • Shenzhen, China
    • Active, not recruiting
    • Peking University Shenzhen Hospital
  • Tianjin, China
    • Active, not recruiting
    • Tianjin Medical University General Hospital
  • Yinchuan, China
    • Active, not recruiting
    • General Hospital of Ningxia Medical University
  • Zhanjiang, China
    • Active, not recruiting
    • Affiliated Hospital of Guangdong Medical University
• Czechia
  • Prague, Czechia
    • Active, not recruiting
    • Vseobecna Fakultni Nemocnice V Praze
• Denmark
  • Copenhagen, Denmark
    • Active, not recruiting
    • Rigshospitalet
  • Kolding, Denmark
    • Active, not recruiting
    • Kolding Sygehus
  • Odense, Denmark
    • Active, not recruiting
    • Odense University Hospital
• France
  • Créteil, France
    • Active, not recruiting
    • Hopital Henri Mondor
  • Grenoble, France
    • Active, not recruiting
    • CHU de Grenoble Hopital Nord
  • La Roche-sur-Yon, France
    • Active, not recruiting
    • Centre Hospitalier Departemental Vendee
  • Marseille, France
    • Active, not recruiting
    • Hopital de la Conception APHM
  • Montpellier, France
    • Active, not recruiting
    • Hopital Lapeyronie pt
  • Paris, France
    • Active, not recruiting
    • Hôpital Necker Enfants Malades
  • Saint-Priest-en-Jarez, France
    • Active, not recruiting
    • CHU Saint Etienne Hopital Nord
  • Gironde
    • Bordeaux, Gironde, France
      • Active, not recruiting
      • Groupe Hospitalier Pellegrin
• Germany
  • Aachen, Germany
    • Active, not recruiting
    • Universitaetsklinikum Aachen AOeR
  • Cologne, Germany
    • Active, not recruiting
    • Universitaetsklinikum Koeln
  • Dresden, Germany
    • Active, not recruiting
    • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Hamburg, Germany
    • Active, not recruiting
    • Universitaetsklinikum Hamburg-Eppendorf
  • Hanover, Germany
    • Active, not recruiting
    • Medizinische Hochschule Hannover
  • Hanover, Germany
    • Active, not recruiting
    • Zentrum Fuer Nieren Hochdruck Und Stoffwechselerkrankungen
  • Lübeck, Germany
    • Active, not recruiting
    • Universitaetsklinikum Schleswig Holstein - Campus Luebeck
  • Mainz, Germany
    • Active, not recruiting
    • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Villingen-Schwenningen, Germany
    • Active, not recruiting
    • Nephrologischen Zentrum Villingen-Schwenningen
• Hong Kong
  • Hong Kong, Hong Kong
    • Active, not recruiting
    • The University of Hong Kong
  • Hong Kong, Hong Kong
    • Active, not recruiting
    • Pok Oi Hospital
  • Hong Kong, Hong Kong
    • Active, not recruiting
    • Princess Margaret Hospital
• Italy
  • Bari, Italy
    • Active, not recruiting
    • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
  • Bologna, Italy
    • Active, not recruiting
    • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
  • Genova, Italy
    • Active, not recruiting
    • IRCCS Ospedale Policlinico San Martino
  • Milan, Italy
    • Active, not recruiting
    • Ospedale San Raffaele
  • Pavia, Italy
    • Active, not recruiting
    • Fondazione Salvatore Maugeri IRCCS
  • Roma, Italy
    • Active, not recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Torino, Italy
    • Withdrawn
    • Ospedale San Giovanni Bosco
• Japan
  • Aichi-ken
    • Kasugai, Aichi-ken, Japan, 486-8510
      • Active, not recruiting
      • Kasugai Municipal Hospital
    • Toyoake, Aichi-ken, Japan, 470-1192
      • Active, not recruiting
      • Fujita Health University Hospital
  • Chiba
    • Chiba, Chiba, Japan, 260-8712
      • Active, not recruiting
      • NHO Chibahigashi National Hospital
    • Ichihara, Chiba, Japan, 299-0112
      • Active, not recruiting
      • Teikyo University Chiba Medical Center
  • Fukuoka
    • Higashi, Fukuoka, Japan, 812-8582
      • Active, not recruiting
      • Kyushu University Hospital
  • Fukuura
    • Yokohama, Fukuura, Japan, 236-0027
      • Active, not recruiting
      • Yokohama City University Hospital
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-0061
      • Active, not recruiting
      • Asahikawa Red Cross Hospital
    • Sapporo, Hokkaido, Japan, 060-8648
      • Active, not recruiting
      • Hokkaido University Hospital
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0017
      • Active, not recruiting
      • Kobe University Hospital
  • Kyoto
    • Kyoto, Kyoto, Japan, 602-8566
      • Active, not recruiting
      • University Hospital, Kyoto Prefectural University of Medicine
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Active, not recruiting
      • Tohoku University Hospital
  • Nara
    • Kashihara, Nara, Japan, 634-8521
      • Active, not recruiting
      • Nara Medical University Hospital
  • Okayama-ken
    • Kitaku, Okayama-ken, Japan, 700-8558
      • Active, not recruiting
      • Okayama University Hospital
  • Osaka
    • Osaka, Osaka, Japan, 545-8586
      • Active, not recruiting
      • Osaka Metropolitan University Hospital
    • Suita, Osaka, Japan, 565-0871
      • Active, not recruiting
      • The University of Osaka Hospital
  • Saitama
    • Kawagoe, Saitama, Japan, 350-8550
      • Active, not recruiting
      • Saitama Medical Center
  • Tokushima
    • Tokushima, Tokushima, Japan, 770-0042
      • Active, not recruiting
      • Tokushima University Hospital
  • Tokyo
    • Tokyo, Tokyo, Japan, 162-8666
      • Active, not recruiting
      • Tokyo Women's Medical University Hospital
  • Tsurumaicho
    • Shōwaku, Tsurumaicho, Japan, 466-8560
      • Active, not recruiting
      • Nagoya University Hospital
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Active, not recruiting
      • Yamaguchi University Hospital
• Malaysia
  • Cheras, Malaysia
    • Active, not recruiting
    • Pusat Perubatan Universiti Kebangsaan Malaysia
  • Ipoh, Malaysia
    • Active, not recruiting
    • Hospital Raja Permaisuri Bainun
  • Kuala Lumpur, Malaysia
    • Active, not recruiting
    • Hospital Kuala Lumpur
  • Kuala Lumpur, Malaysia
    • Active, not recruiting
    • University Malaya Medical Centre
  • Kuantan, Malaysia
    • Active, not recruiting
    • Hospital Tengku Ampuan Afzan
  • Petaling Jaya, Malaysia
    • Active, not recruiting
    • Sunway Medical Centre
  • Selangor
    • Kajang, Selangor, Malaysia, 43000
      • Active, not recruiting
      • Hospital Serdang
• Mexico
  • Aguascalientes, Mexico
    • Recruiting
    • Centenario Hospital Miguel Hidalgo
  • Chihuahua City, Mexico
    • Active, not recruiting
    • Servicios Hospitalarios De Mexico S A De C V
  • Culiacán, Mexico
    • Active, not recruiting
    • Neurociencias Estudios Clinicos
  • Guadalajara, Mexico
    • Active, not recruiting
    • Hospital Civil Fray Antonio Alcalde
  • Monterrey, Mexico
    • Recruiting
    • Hospital Universitario Dr. Jose Eleuterio Gonzalez
• New Zealand
  • Auckland, New Zealand, 1023
    • Active, not recruiting
    • Auckland City Hospital
  • Dunedin, New Zealand
    • Active, not recruiting
    • Dunedin Hospital
  • Hamilton, New Zealand, 3204
    • Active, not recruiting
    • Waikato Hospital
• Portugal
  • Braga, Portugal
    • Active, not recruiting
    • Centro Clinico Academico Braga, Associação (2CA-Braga)
  • Carnaxide, Portugal
    • Active, not recruiting
    • Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
  • Lisbon, Portugal
    • Active, not recruiting
    • Centro Hospitalar Universitario Lisboa Central E.P.E. Hospital Curry Cabral
  • Lisbon, Portugal
    • Active, not recruiting
    • Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital de Santa Maria
  • Loures, Portugal
    • Active, not recruiting
    • Hospital de Loures, E.P.E.
  • Porto, Portugal
    • Active, not recruiting
    • Unidade Local de Saúde de São João, E.P.E
  • Setúbal, Portugal
    • Active, not recruiting
    • Centro Hospitalar de Setúbal, E.P.E., Hospital de São Bernardo
  • Vila Franca de Xira, Portugal
    • Active, not recruiting
    • Unidade Local de Saude do Estuario Tejo E.P.E., Hospital Vila Franca de Xira
  • Vila Nova de Gaia, Portugal
    • Active, not recruiting
    • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
• Spain
  • Almería, Spain
    • Active, not recruiting
    • Torrecárdenas University Hospital
  • Barcelona, Spain
    • Active, not recruiting
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain
    • Active, not recruiting
    • Hospital del Mar
  • Barcelona, Spain
    • Active, not recruiting
    • Fundacion Puigvert
  • Córdoba, Spain
    • Active, not recruiting
    • Hospital Universitario Reina Sofia
  • Madrid, Spain
    • Active, not recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Active, not recruiting
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain
    • Active, not recruiting
    • Hospital Universitario Clínico San Carlos
  • Majadahonda, Spain
    • Active, not recruiting
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Seville, Spain
    • Active, not recruiting
    • Hospital Universitario Virgen del Rocio
  • Seville, Spain
    • Active, not recruiting
    • Hospital Universitario Virgen Macarena
• Taiwan
  • Hualien City, Taiwan
    • Active, not recruiting
    • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  • Kaohsiung City, Taiwan
    • Active, not recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • New Taipei City, Taiwan
    • Active, not recruiting
    • Far Eastern Memorial Hospital
  • New Taipei City, Taiwan
    • Active, not recruiting
    • Shuangho Hospital Ministry of Health and Welfare
  • Taichung, Taiwan
    • Active, not recruiting
    • China Medical University Hospital
  • Tainan, Taiwan
    • Active, not recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan
    • Active, not recruiting
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Active, not recruiting
    • Taipei Medical University Hospital
• Thailand
  • Bangkok, Thailand
    • Active, not recruiting
    • Phramongkutklao Hospital
  • Bangkoknoi, Thailand
    • Active, not recruiting
    • Siriraj Hospital
  • Chiang Mai, Thailand
    • Active, not recruiting
    • Maharaj Nakorn Chiang Mai Hospital
  • Hat Yai, Thailand
    • Active, not recruiting
    • Songklanagarind Hospital
  • Khon Kaen, Thailand
    • Active, not recruiting
    • Srinagarind Hospital
  • Pathum Wan, Thailand
    • Active, not recruiting
    • King Chulalongkorn Memorial Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Active, not recruiting
    • Ankara Training and Research Hospital
  • Ankara, Turkey (Türkiye)
    • Active, not recruiting
    • Hacettepe University Medical Faculty
  • Antalya, Turkey (Türkiye)
    • Active, not recruiting
    • Akdeniz University Faculty of Medicine
  • Bursa, Turkey (Türkiye)
    • Active, not recruiting
    • Uludag University Medical Faculty
  • Edirne, Turkey (Türkiye)
    • Active, not recruiting
    • Trakya University Medical Faculty
  • Erciyes, Turkey (Türkiye)
    • Active, not recruiting
    • Erciyes University Medical Faculty
  • Istanbul, Turkey (Türkiye)
    • Active, not recruiting
    • Istanbul University Cerrahpasa Medical Faculty
  • Kocaeli, Turkey (Türkiye)
    • Active, not recruiting
    • Kocaeli University Research and Application Hospital
• United Kingdom
  • Birmingham, United Kingdom, B15 2GW
    • Active, not recruiting
    • Queen Elizabeth Hospital Birmingham
  • Bristol, United Kingdom
    • Active, not recruiting
    • Southmead Hospital
  • Canterbury, United Kingdom, CT1 3NG
    • Active, not recruiting
    • Kent and Canterbury Hospital
  • Carshalton, United Kingdom
    • Active, not recruiting
    • St. Helier Hospital
  • Coventry, United Kingdom
    • Active, not recruiting
    • University Hospital Coventry & Warwickshire
  • Glasgow, United Kingdom
    • Active, not recruiting
    • Queen Elizabeth University Hospital
  • Leicester, United Kingdom
    • Active, not recruiting
    • Leicester General Hospital
  • London, United Kingdom
    • Recruiting
    • King's College Hospital
  • London, United Kingdom
    • Active, not recruiting
    • Hammersmith Hospital
  • London, United Kingdom
    • Recruiting
    • Great Ormond Street Hospital for Children
  • Manchester, United Kingdom
    • Recruiting
    • Royal Manchester Childrens Hospital
  • Manchester, United Kingdom
    • Active, not recruiting
    • Royal Berkshire Hospital
  • Nottingham, United Kingdom
    • Recruiting
    • Nottingham City Hospital
  • Salford, United Kingdom
    • Active, not recruiting
    • Salford Care Organisation
  • Sheffield, United Kingdom
    • Active, not recruiting
    • Northern General Hospital
  • Stevenage, United Kingdom, SG1 4AB
    • Active, not recruiting
    • Lister Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Active, not recruiting
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Phoenix Children's Hospital
    • Phoenix, Arizona, United States, 85027
      • Active, not recruiting
      • Arizona Kidney Disease and Hypertension Center
  • California
    • Loma Linda, California, United States, 92354
      • Active, not recruiting
      • Loma Linda University Medical Center
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
    • Northridge, California, United States, 91324
      • Active, not recruiting
      • Amicis Research Centre
    • Northridge, California, United States, 91324
      • Active, not recruiting
      • Northridge Clinical Research Inc.
    • Oakland, California, United States, 94612
      • Recruiting
      • Kaiser Permanente
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California Davis Health System
    • San Diego, California, United States, 92103
      • Active, not recruiting
      • Scripps Health
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Hospital and Clinic
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • University of Colorado Anschutz Medical Campus
    • Denver, Colorado, United States, 80230
      • Recruiting
      • Denver Nephrology Research Division
  • Florida
    • Coral Springs, Florida, United States, 33071
      • Active, not recruiting
      • South Florida Nephrology Group, P.A.
    • Miami, Florida, United States, 33155
      • Recruiting
      • Nicklaus Children's Hospital
    • Orlando, Florida, United States, 32806
      • Recruiting
      • CTR Oakwater LLC
  • Georgia
    • Atlanta, Georgia, United States, 30307
      • Recruiting
      • Emory University School of Medicine
    • Lawrenceville, Georgia, United States, 30046
      • Active, not recruiting
      • Georgia Nephrology
  • Idaho
    • Boise, Idaho, United States, 83706
      • Active, not recruiting
      • Boise Kidney
    • Idaho Falls, Idaho, United States, 83404
      • Active, not recruiting
      • CARE Institute - Idaho Falls
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Active, not recruiting
      • University of Chicago
    • Evanston, Illinois, United States, 60201
      • Active, not recruiting
      • Northshore University Healthsystem
    • Oak Brook, Illinois, United States, 60523
      • Active, not recruiting
      • Nephrology Associates of Northern Illinois and Indiana (NANI Research)
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Active, not recruiting
      • University of Louisville
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Active, not recruiting
      • The Johns Hopkins Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Active, not recruiting
      • Intermed Consultants
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Active, not recruiting
      • CARE Institute - Nephrology & Hypertension Associates
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Children's Mercy Research Institute
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University, School of Medicine
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Active, not recruiting
      • Somnos Clinical Research
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack University Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Active, not recruiting
      • Renal Medicine Associates
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • ICAHN School of Medicine at Mount Sinai
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28105
      • Recruiting
      • Atrium Health
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Active, not recruiting
      • University Hospitals Cleveland Medical Center
    • Cleveland, Ohio, United States, 44195
      • Active, not recruiting
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Active, not recruiting
      • Ohio State University
  • Oregon
    • Roseburg, Oregon, United States, 97471
      • Active, not recruiting
      • Kidney and Hypertension Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Active, not recruiting
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • The Childrens Hospital of Philadelphia Kohls GI Nutrition and Diagnostic Center
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Active, not recruiting
      • South Carolina Clinical Research
    • Spartanburg, South Carolina, United States, 29306
      • Active, not recruiting
      • Carolina Nephrology, PA
  • Texas
    • Arlington, Texas, United States, 76015
      • Active, not recruiting
      • Arlington Nephrology
    • Dallas, Texas, United States, 75231
      • Active, not recruiting
      • Nephrotex Research Group
    • Dallas, Texas, United States, 75235
      • Active, not recruiting
      • Renal Disease Research Institute, LLC - Dallas
    • El Paso, Texas, United States, 79902
      • Active, not recruiting
      • MedResearch, Inc
    • Galveston, Texas, United States, 77555
      • Active, not recruiting
      • University Texas Medical Branch
    • Houston, Texas, United States, 77054
      • Active, not recruiting
      • Kaleidoscope Clinical Research
    • Webster, Texas, United States, 77598
      • Active, not recruiting
      • Clear Lake Specialties
  • Utah
    • Salt Lake City, Utah, United States, 84115
      • Active, not recruiting
      • Utah Kidney Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Patients will receive 120 mg immediate release capsules of Placebo twice daily	Drug: Placebo; Patients will receive 120 mg capsules of Placebo twice daily
Experimental: 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)	Drug: DMX-200; DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor.; Other Names: Repagermanium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the efficacy of DMX-200 in terms of urine protein/creatinine ratio (PCR) in patients with FSGS who are receiving an ARB.	Percent change in urine PCR (based on 24-hour urine collection)	Baseline to Week 35
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).	Slope of eGFR	Baseline to Week 104
OLE - Assess the long-term safety and tolerability of open-label treatment with DMX-200 in patients with FSGS who are receiving an ARB.	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.	Double-blind baseline to Week 216

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of DMX-200 on kidney function parameters including proteinuria in patients with FSGS who are receiving an ARB.	Proportion of responders and non-responders following treatment with DMX-200 compared with placebo. Proportion of patients on treatment with DMX-200 compared with placebo that meet a composite endpoint of worsening in kidney function.	Baseline to Week 104
OLE - Assess the long-term efficacy of open-label treatment with DMX-200 in patients with FSGS who are receiving an ARB.	Slope of eGFR and percent change in urine PCR	From Week 108 (Baseline) at each visit
OLE - Evaluate the long-term effect of open-label treatment with DMX-200 on kidney function parameters in patients with FSGS who are receiving an ARB.	Proportion of patients on treatment with DMX-200 that meet a composite endpoint of worsening in kidney function.	Double blind baseline to Week 216
Evaluate the incidence and severity of AEs with treatment of DMX-200 in adult and adolescent patients with FSGS who are receiving an ARB.	Incidence and severity of AEs and clinically significant changes following treatment with DMX-200 compared with placebo.	Baseline to Week 104

Collaborators and Investigators

• Sponsor: Dimerix Bioscience Pty Ltd
• Investigators: Study Director: David Fuller, Dimerix Bioscience Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: kidney disease; focal segmental glomerulosclerosis; fsgs
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Glomerulonephritis; Nephritis; Kidney Diseases; Glomerulosclerosis, Focal Segmental; Substandard Drugs; Pharmaceutical Preparations; propagermanium
• Other Study ID Numbers: DMX-200-301; 2023-504597-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No