FSGSPhase 3ACTION3NCT05183646
A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
A Phase 3 study testing DMX-200 in people with FSGS, run by Dimerix Bioscience Pty Ltd at 220 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- FSGS
- What is being tested?
- DMX-200
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 220 sitesin 21 countries
- Study dates
- 30 May 2022to Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be 12 to 80 years old
- A diagnosis of primary FSGS, genetic FSGS, or FSGS of undetermined cause. Confirmed by kidney biopsy within 7 years of screening
- Must be either receiving an ARB at the maximal tolerated dose or willing to transition
- If taking corticosteroids, the dosage must be stable for ≥4 weeks prior to Screening and during Stabilization
- 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
- 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.
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- 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)
- 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
- 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.
- 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:
- Is not of childbearing potential
- If of childbearing potential and beginning at menarche, agrees to use a highly effective method of contraception consistently during the treatment period.
- A male patient with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception
- 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.
- 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.
- 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
- The patient received blinded Investigational Product throughout the duration of the double-blind period up to the Week 104 visit
- The patient continues to meet the contraceptive requirements
Who cannot join
- Has FSGS secondary to another condition.
- 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).
- History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin [HbA1c] >8% at Screening)
- 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).
- Active clinically significant hepatobiliary disease.
- Documented history of heart failure (New York Heart Association Class III/IV) or a major adverse cardiac event within 12 weeks prior to Screening.
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- Has a physical, medical, or psychological condition, that in the opinion of the Investigator, may interfere with the evaluation the study.
- The patient has a history of alcohol or illicit drug use disorder within 1 year prior to Screening.
- Had a prior organ transplant or stem cell transplant, with the exception of corneal transplant.
- 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.
- Serum potassium levels >5.5 mmol/L at Screening.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 × upper limit of normal (ULN) at Screening.
- 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.
- History of serious side effects or allergic response to an angiotensin II antagonist or has a known sensitivity to any components in the IP.
- Unable to swallow oral medication.
- Prior participation in any Dimerix-sponsored DMX-200 clinical study.
- 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.
- Are study site personnel directly affiliated with this study and their immediate families
- OLE PERIOD
- The patient has met the criteria for permanent IP discontinuation or study discontinuation
- 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.
Trial locations and contacts
220 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
220 sites in 21 countries
United States54 sites, 20 recruiting
- Active, not recruiting
Renal Medicine Associates
Albuquerque, New Mexico, 87109
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Active, not recruiting
Arlington Nephrology
Arlington, Texas, 76015
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30307
- Active, not recruiting
The Johns Hopkins Hospital
Baltimore, Maryland, 21205
- Active, not recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
- Active, not recruiting
Boise Kidney
Boise, Idaho, 83706
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
- Recruiting
Atrium Health
Charlotte, North Carolina, 28105
- Active, not recruiting
University of Chicago
Chicago, Illinois, 60637
- Active, not recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Active, not recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Active, not recruiting
Ohio State University
Columbus, Ohio, 43210
- Active, not recruiting
South Florida Nephrology Group, P.A.
Coral Springs, Florida, 33071
- Active, not recruiting
Nephrotex Research Group
Dallas, Texas, 75231
- Active, not recruiting
Renal Disease Research Institute, LLC - Dallas
Dallas, Texas, 75235
- Recruiting
University of Colorado Anschutz Medical Campus
Denver, Colorado, 80204
- Recruiting
Denver Nephrology Research Division
Denver, Colorado, 80230
- Active, not recruiting
Intermed Consultants
Edina, Minnesota, 55435
- Active, not recruiting
MedResearch, Inc
El Paso, Texas, 79902
- Active, not recruiting
NorthShore University HealthSystem
Evanston, Illinois, 60201
- Active, not recruiting
University Texas Medical Branch
Galveston, Texas, 77555
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Active, not recruiting
Kaleidoscope Clinical Research
Houston, Texas, 77054
- Active, not recruiting
CARE Institute - Idaho Falls
Idaho Falls, Idaho, 83404
- Recruiting
Children's Mercy Research Institute
Kansas City, Missouri, 64111
- Active, not recruiting
Georgia Nephrology
Lawrenceville, Georgia, 30046
- Active, not recruiting
Somnos Clinical Research
Lincoln, Nebraska, 68510
- Active, not recruiting
Loma Linda University Medical Center
Loma Linda, California, 92354
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
- Active, not recruiting
University of Louisville
Louisville, Kentucky, 40202
- Recruiting
Nicklaus Children's Hospital
Miami, Florida, 33155
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Active, not recruiting
South Carolina Clinical Research
North Charleston, South Carolina, 29406
- Active, not recruiting
Amicis Research Centre
Northridge, California, 91324
- Active, not recruiting
Northridge Clinical Research Inc.
Northridge, California, 91324
- Active, not recruiting
Nephrology Associates of Northern Illinois and Indiana (NANI Research)
Oak Brook, Illinois, 60523
- Recruiting
Kaiser Permanente
Oakland, California, 94612
- Recruiting
CTR Oakwater LLC
Orlando, Florida, 32806
- Recruiting
The Childrens Hospital of Philadelphia Kohls GI Nutrition and Diagnostic Center
Philadelphia, Pennsylvania, 19104
- Active, not recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
- Active, not recruiting
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, 85027
- Active, not recruiting
Kidney and Hypertension Center
Roseburg, Oregon, 97471
- Recruiting
University of California Davis Health System
Sacramento, California, 95817
- Active, not recruiting
Utah Kidney Research Institute
Salt Lake City, Utah, 84115
- Active, not recruiting
Scripps Health
San Diego, California, 92103
- Active, not recruiting
Carolina Nephrology, PA
Spartanburg, South Carolina, 29306
- Recruiting
Washington University, School of Medicine
St Louis, Missouri, 63110
- Recruiting
Stanford Hospital and Clinic
Stanford, California, 94305
- Active, not recruiting
CARE Institute - Nephrology & Hypertension Associates
Tupelo, Mississippi, 38801
- Active, not recruiting
Clear Lake Specialties
Webster, Texas, 77598
Japan20 sites
- Active, not recruiting
Asahikawa Red Cross Hospital
Asahikawa, Hokkaido, 070-0061
- Active, not recruiting
NHO Chibahigashi National Hospital
Chiba, Chiba, 260-8712
- Active, not recruiting
Kyushu University Hospital
Higashi, Fukuoka, 812-8582
- Active, not recruiting
Teikyo University Chiba Medical Center
Ichihara, Chiba, 299-0112
- Active, not recruiting
Nara Medical University Hospital
Kashihara, Nara, 634-8521
- Active, not recruiting
Kasugai Municipal Hospital
Kasugai, Aichi-ken, 486-8510
- Active, not recruiting
Saitama Medical Center
Kawagoe, Saitama, 350-8550
- Active, not recruiting
Okayama University Hospital
Kitaku, Okayama-ken, 700-8558
- Active, not recruiting
Kobe University Hospital
Kobe, Hyōgo, 650-0017
- Active, not recruiting
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
- Active, not recruiting
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586
- Active, not recruiting
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
- Active, not recruiting
Tohoku University Hospital
Sendai, Miyagi, 980-8574
- Active, not recruiting
Nagoya University Hospital
Shōwaku, Tsurumaicho, 466-8560
- Active, not recruiting
The University of Osaka Hospital
Suita, Osaka, 565-0871
- Active, not recruiting
Tokushima University Hospital
Tokushima, Tokushima, 770-0042
- Active, not recruiting
Tokyo Women's Medical University Hospital
Tokyo, Tokyo, 162-8666
- Active, not recruiting
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192
- Active, not recruiting
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505
- Active, not recruiting
Yokohama City University Hospital
Yokohama, Fukuura, 236-0027
China19 sites
- Active, not recruiting
The First Affiliated Hospital of Baotou Medical College
Baotou
- Active, not recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing
- Active, not recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing
- Active, not recruiting
Peking University First Hospital
Beijing
- Active, not recruiting
Peking University People's Hospital
Beijing
- Active, not recruiting
Sichuan Provincial People's Hospital
Chengdu
- Active, not recruiting
West China Hospital, Sichuan University
Chengdu
- Active, not recruiting
Guangdong Provincial People's Hospital
Guangzhou
- Active, not recruiting
The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou
- Active, not recruiting
Zhejiang Provincial People's Hospital
Hangzhou
- Active, not recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot
- Active, not recruiting
Shandong Provincial Hospital
Jinan
- Active, not recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
- Active, not recruiting
Jiangsu Province Hospital
Nanjing
- Active, not recruiting
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai
- Active, not recruiting
Peking University Shenzhen Hospital
Shenzhen
- Active, not recruiting
Tianjin Medical University General Hospital
Tianjin
- Active, not recruiting
General Hospital of Ningxia Medical University
Yinchuan
- Active, not recruiting
Affiliated Hospital of Guangdong Medical University
Zhanjiang
United Kingdom16 sites, 4 recruiting
- Active, not recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
- Active, not recruiting
Southmead Hospital
Bristol
- Active, not recruiting
Kent and Canterbury Hospital
Canterbury, CT1 3NG
- Active, not recruiting
St. Helier Hospital
Carshalton
- Active, not recruiting
University Hospital Coventry & Warwickshire
Coventry
- Active, not recruiting
Queen Elizabeth University Hospital
Glasgow
- Active, not recruiting
Leicester General Hospital
Leicester
- Recruiting
Great Ormond Street Hospital for Children
London
- Active, not recruiting
Hammersmith Hospital
London
- Recruiting
King's College Hospital
London
- Active, not recruiting
Royal Berkshire Hospital
Manchester
- Recruiting
Royal Manchester Childrens Hospital
Manchester
- Recruiting
Nottingham City Hospital
Nottingham
- Active, not recruiting
Salford Care Organisation
Salford
- Active, not recruiting
Northern General Hospital
Sheffield
- Active, not recruiting
Lister Hospital
Stevenage, SG1 4AB
Spain11 sites
- Active, not recruiting
Torrecárdenas University Hospital
Almería
- Active, not recruiting
Fundacion Puigvert
Barcelona
- Active, not recruiting
Hospital del Mar
Barcelona
- Active, not recruiting
Hospital Universitari Vall d'Hebron
Barcelona
- Active, not recruiting
Hospital Universitario Reina Sofia
Córdoba
- Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid
- Active, not recruiting
Hospital Universitario Clinico San Carlos
Madrid
- Active, not recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid
- Active, not recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
- Active, not recruiting
Hospital Universitario Virgen del Rocio
Seville
- Active, not recruiting
Hospital Universitario Virgen Macarena
Seville
Australia10 sites
- Active, not recruiting
Griffith University
Brisbane
- Active, not recruiting
Princess Alexandra Hospital
Brisbane
- Active, not recruiting
Austin Hospital
Melbourne
- Active, not recruiting
Monash Health
Melbourne
- Active, not recruiting
St Vincent's Hospital Melbourne
Melbourne
- Active, not recruiting
Western Health
Melbourne
- Active, not recruiting
John Hunter Hospital
Sydney
- Active, not recruiting
Liverpool Hospital
Sydney
- Active, not recruiting
Nepean Hospital
Sydney
- Active, not recruiting
Royal North Shore Hospital
Sydney
Germany9 sites
- Active, not recruiting
Universitaetsklinikum Aachen AOeR
Aachen
- Active, not recruiting
Universitaetsklinikum Koeln
Cologne
- Active, not recruiting
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden
- Active, not recruiting
Universitaetsklinikum Hamburg-Eppendorf
Hamburg
- Active, not recruiting
Medizinische Hochschule Hannover
Hanover
- Active, not recruiting
Zentrum fuer Nieren Hochdruck und Stoffwechselerkrankungen
Hanover
- Active, not recruiting
Universitaetsklinikum Schleswig Holstein - Campus Luebeck
Lübeck
- Active, not recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz
- Active, not recruiting
Nephrologischen Zentrum Villingen-Schwenningen
Villingen-Schwenningen
Portugal9 sites
- Active, not recruiting
Centro Clinico Academico Braga, Associação (2CA-Braga)
Braga
- Active, not recruiting
Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
Carnaxide
- Active, not recruiting
Centro Hospitalar Universitario Lisboa Central E.P.E. Hospital Curry Cabral
Lisbon
- Active, not recruiting
Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital de Santa Maria
Lisbon
- Active, not recruiting
Hospital de Loures, E.P.E.
Loures
- Active, not recruiting
Unidade Local de Saúde de São João, E.P.E
Porto
- Active, not recruiting
Centro Hospitalar de Setúbal, E.P.E., Hospital de São Bernardo
Setúbal
- Active, not recruiting
Unidade Local de Saude do Estuario Tejo E.P.E., Hospital Vila Franca de Xira
Vila Franca de Xira
- Active, not recruiting
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Vila Nova de Gaia
Argentina8 sites, 2 recruiting
- Active, not recruiting
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
Buenos Aires
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires
- Active, not recruiting
Organizacion Medica de Investigacion (OMI)
CABA
- Active, not recruiting
Centro Médico de Nutrición y Diabetes-CENUDIAB
Ciudad Autonoma Buenos Aires
- Active, not recruiting
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires
- Active, not recruiting
Hospital General de Agudos Dr. Cosme Argerich
Ciudad Autonoma Buenos Aires
- Active, not recruiting
Clinica Privada Velez Sarsfield
Córdoba
- Recruiting
Clinica de Nefrologia Urologia y Enf. Cardiovasculares S.A.
Santa Fe
France8 sites
- Active, not recruiting
Groupe Hospitalier Pellegrin
Bordeaux, Gironde
- Active, not recruiting
Hôpital Henri Mondor
Créteil
- Active, not recruiting
CHU de Grenoble Hopital Nord
Grenoble
- Active, not recruiting
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon
- Active, not recruiting
Hopital de la Conception APHM
Marseille
- Active, not recruiting
Hopital Lapeyronie pt
Montpellier
- Active, not recruiting
Hôpital Necker Enfants Malades
Paris
- Active, not recruiting
CHU Saint Etienne Hôpital Nord
Saint-Priest-en-Jarez
Taiwan8 sites
- Active, not recruiting
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City
- Active, not recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
- Active, not recruiting
Far Eastern Memorial Hospital
New Taipei City
- Active, not recruiting
Shuangho Hospital Ministry of Health and Welfare
New Taipei City
- Active, not recruiting
China Medical University Hospital
Taichung
- Active, not recruiting
National Cheng Kung University Hospital
Tainan
- Active, not recruiting
National Taiwan University Hospital
Taipei
- Active, not recruiting
Taipei Medical University Hospital
Taipei
Turkey (Türkiye)8 sites
- Active, not recruiting
Ankara Training and Research Hospital
Ankara
- Active, not recruiting
Hacettepe University Medical Faculty
Ankara
- Active, not recruiting
Akdeniz University Faculty of Medicine
Antalya
- Active, not recruiting
Uludag University Medical Faculty
Bursa
- Active, not recruiting
Trakya University Medical Faculty
Edirne
- Active, not recruiting
Erciyes University Medical Faculty
Erciyes
- Active, not recruiting
Istanbul University Cerrahpasa Medical Faculty
Istanbul
- Active, not recruiting
Kocaeli University Research and Application Hospital
Kocaeli
Italy7 sites
- Active, not recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari
- Active, not recruiting
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna
- Active, not recruiting
IRCCS Ospedale Policlinico San Martino
Genova
- Active, not recruiting
Ospedale San Raffaele
Milan
- Active, not recruiting
Fondazione Salvatore Maugeri IRCCS
Pavia
- Active, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
- Withdrawn
Ospedale San Giovanni Bosco
Torino
Malaysia7 sites
- Active, not recruiting
Pusat Perubatan Universiti Kebangsaan Malaysia
Cheras
- Active, not recruiting
Hospital Raja Permaisuri Bainun
Ipoh
- Active, not recruiting
Hospital Serdang
Kajang, Selangor, 43000
- Active, not recruiting
Hospital Kuala Lumpur
Kuala Lumpur
- Active, not recruiting
University Malaya Medical Centre
Kuala Lumpur
- Active, not recruiting
Hospital Tengku Ampuan Afzan
Kuantan
- Active, not recruiting
Sunway Medical Centre
Petaling Jaya
Thailand6 sites
- Active, not recruiting
Phramongkutklao Hospital
Bangkok
- Active, not recruiting
Siriraj Hospital
Bangkoknoi
- Active, not recruiting
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
- Active, not recruiting
Songklanagarind Hospital
Hat Yai
- Active, not recruiting
Srinagarind Hospital
Khon Kaen
- Active, not recruiting
King Chulalongkorn Memorial Hospital
Pathum Wan
Brazil5 sites
- Active, not recruiting
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu
- Active, not recruiting
Hospital das Clínicas da Universidade Federal de Pernambuco
Recife
- Active, not recruiting
HUPE-UERJ - Hospital Universitário Pedro Ernesto - Universidade Estadual do Rio de Janeiro
Rio de Janeiro
- Active, not recruiting
Fundação Oswaldo Ramos - Hospital do Rim
São Paulo
- Active, not recruiting
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo
Mexico5 sites, 2 recruiting
- Recruiting
Centenario Hospital Miguel Hidalgo
Aguascalientes
- Active, not recruiting
Servicios Hospitalarios De Mexico S A De C V
Chihuahua City
- Active, not recruiting
Neurociencias Estudios Clinicos
Culiacán
- Active, not recruiting
Hospital Civil Fray Antonio Alcalde
Guadalajara
- Recruiting
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey
Denmark3 sites
- Active, not recruiting
Rigshospitalet
Copenhagen
- Active, not recruiting
Kolding Sygehus
Kolding
- Active, not recruiting
Odense University Hospital
Odense
Hong Kong3 sites
- Active, not recruiting
Pok Oi Hospital
Hong Kong
- Active, not recruiting
Princess Margaret Hospital
Hong Kong
- Active, not recruiting
The University of Hong Kong
Hong Kong
New Zealand3 sites
- Active, not recruiting
Auckland City Hospital
Auckland, 1023
- Active, not recruiting
Dunedin Hospital
Dunedin
- Active, not recruiting
Waikato Hospital
Hamilton, 3204
Czechia1 site
- Active, not recruiting
Všeobecná fakultní nemocnice v Praze
Prague
About this study
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)
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.
Read the 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.
- Conditions
- FSGS
- Being tested
- DMX-200, Placebo
- Keywords
- fsgs, focal segmental glomerulosclerosis, kidney disease
- Medical subject headings
- Glomerulosclerosis, Focal Segmental, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMX-200Drug
Also called Repagermanium
DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor.
PlaceboDrug
Patients will receive 120 mg capsules of Placebo twice daily
| Study group | Role | What they receive |
|---|---|---|
| DMX-200 (repagermanium) | Experimental | 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) Receives: Drug: DMX-200 |
| Placebo | Placebo comparator | Patients will receive 120 mg immediate release capsules of Placebo twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.
Measured: Double-blind baseline to Week 216
Secondary outcomes (4)
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.
Measured: Baseline to Week 104
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.
Measured: 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
Measured: 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.
Measured: Double blind baseline to Week 216
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start30 May 2022
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FSGSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dimerix Bioscience Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Fuller, Study director, Dimerix Bioscience Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183646
- Sponsor's protocol ID
- DMX-200-301
- Other IDs
- 2023-504597-37, 2023
- Acronym
- ACTION3
- Status last verified
- Feb 2026
- First submitted
- 29 Nov 2021
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meliambro K, He JC, Campbell KN. Podocyte-targeted therapies - progress and future directions. Nat Rev Nephrol. 2024 Oct;20(10):643-658. doi: 10.1038/s41581-024-00843-z. Epub 2024 May 9.
PubMed 38724717