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A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
Sponsor: Dimerix Bioscience Pty Ltd
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
No
Conditions
Interventions
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
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
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
NHO Chibahigashi National Hospital
Chiba, Chiba, 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
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Okayama University Hospital
Kitaku, Okayama-ken, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Tokushima University Hospital
Tokushima, Tokushima, Japan
Tokyo Women's Medical University Hospital
Tokyo, Tokyo, Japan
Nagoya University Hospital
Shōwaku, Tsurumaicho, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, 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