Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
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

No

Conditions

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

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