A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
Launched by DIMERIX BIOSCIENCE PTY LTD · Jan 5, 2022
Trial Information
Current as of August 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called DMX-200, which is designed to help patients with a kidney condition known as FSGS (Focal Segmental Glomerulosclerosis). The trial will compare DMX-200 to a placebo (a non-active treatment) over a period of 2 years to see how effective and safe it is for patients who are already taking another medication called an ARB. The trial is open to adults aged 12 to 80 who have been diagnosed with FSGS. To participate, individuals need to have certain health conditions, such as a specific level of protein in their urine, and must be stable on their current medications.
Participants can expect to take DMX-200 or a placebo twice daily for 104 weeks, followed by a chance to continue receiving the treatment for an additional 2 years in an open-label phase, where everyone knows they are receiving the active medication. Throughout the trial, participants will have regular check-ups to monitor their health and how well the treatment is working. It's important for potential participants to discuss their eligibility with their healthcare provider, as there are specific criteria regarding previous health conditions and current medications.
Gender
ALL
Eligibility criteria
- • 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.
About Dimerix Bioscience Pty Ltd
Dimerix Bioscience Pty Ltd is a clinical-stage biotechnology company focused on developing innovative therapeutics for unmet medical needs, particularly in the fields of kidney disease and inflammatory disorders. Leveraging its proprietary drug development platform, Dimerix is dedicated to advancing its lead candidates through rigorous clinical trials, aiming to improve patient outcomes and enhance quality of life. With a commitment to scientific excellence and collaboration, the company actively engages with healthcare professionals and research institutions to foster the development of transformative therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Los Angeles, California, United States
Chicago, Illinois, United States
London, , United Kingdom
Loma Linda, California, United States
Los Angeles, California, United States
Hackensack, New Jersey, United States
Barcelona, , Spain
Phoenix, Arizona, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Sapporo, Hokkaido, Japan
Birmingham, Alabama, United States
Miami, Florida, United States
Louisville, Kentucky, United States
New York, New York, United States
Kaohsiung, , Taiwan
Hannover, , Germany
Baltimore, Maryland, United States
Nottingham, , United Kingdom
Dunedin, , New Zealand
Taipei, , Taiwan
Sendai, Miyagi, Japan
Taichung, , Taiwan
Odense, , Denmark
London, , United Kingdom
Khon Kaen, , Thailand
Créteil, , France
Paris, , France
Kyoto, , Japan
Bangkok, , Thailand
Sevilla, , Spain
Hong Kong, , Hong Kong
Kolding, , Denmark
Kobe, Hyogo, Japan
Leicester, , United Kingdom
Hamburg, , Germany
Hamilton, , New Zealand
Ciudad Autonoma De Buenos Aires, , Argentina
Kuala Lumpur, , Malaysia
Auckland, , New Zealand
Sacramento, California, United States
Evanston, Illinois, United States
Sheffield, , United Kingdom
Tainan, , Taiwan
Barcelona, , Spain
Barcelona, Catalonia, Spain
Milano, , Italy
Nanjing, Jiangsu, China
Cleveland, Ohio, United States
Brisbane, , Australia
Ankara, , Turkey
Toyoake, Aichi, Japan
Coventry, , United Kingdom
Bristol, , United Kingdom
Sydney, New South Wales, Australia
Beijing, , China
Torino, , Italy
Ube, Yamaguchi, Japan
Madrid, , Spain
St. Louis, Missouri, United States
Majadahonda, , Spain
Glasgow, , United Kingdom
Nanchang, , China
Beijing, , China
Stevenage, , United Kingdom
Sydney, , Australia
Aguascalientes, , Mexico
Córdoba, , Spain
London, , United Kingdom
Kuala Lumpur, , Malaysia
Guangzhou, , China
Chengdu, , China
Sevilla, , Spain
Tokyo, , Japan
Kajang, Selangor, Malaysia
Kawagoe, Saitama, Japan
Kuantan, , Malaysia
Tianjin, , China
Oakland, California, United States
New Taipei City, , Taiwan
Atlanta, Georgia, United States
Istanbul, , Turkey
Koeln, , Germany
Hong Kong, , Hong Kong
Roseburg, Oregon, United States
Canterbury, , United Kingdom
Chengdu, , China
Arlington, Texas, United States
Sydney, , Australia
Albuquerque, New Mexico, United States
Bari, , Italy
Pavia, , Italy
Northridge, California, United States
Jinan, , China
Mainz, , Germany
Guadalajara, , Mexico
Edirne, , Turkey
Yinchuan, , China
Melbourne, , Australia
Galveston, Texas, United States
Hangzhou, , China
Beijing, , China
Melbourne, , Australia
Dresden, , Germany
Webster, Texas, United States
Ankara, , Turkey
Kocaeli, , Turkey
Osaka, , Japan
Higashi, Fukuoka, Japan
Madrid, , Spain
Birmingham, , United Kingdom
Dallas, Texas, United States
San Diego, California, United States
Dallas, Texas, United States
Bursa, , Turkey
Shenzhen, Guangdong, China
Hong Kong, , Hong Kong
Beijing, , China
Ciudad Autonoma Buenos Aires, , Argentina
Lawrenceville, Georgia, United States
Kasugai, Aichi, Japan
Melbourne, , Australia
Lincoln, Nebraska, United States
Hat Yai, , Thailand
La Roche Sur Yon, , France
Taipei City, , Taiwan
Roma, , Italy
Salt Lake City, Utah, United States
Copenhagen, Hovedstaden, Denmark
Madrid, Comunidad De Madrid, Spain
São Paulo, , Brazil
Bologna, , Italy
Bangkoknoi, , Thailand
Carnaxide, , Portugal
Genova, , Italy
Baotou, , China
Hohhot, , China
Marseille, , France
Petaling Jaya, , Malaysia
Hangzhou, , China
Zhanjiang, , China
Edina, Minnesota, United States
Phoenix, Arizona, United States
Northridge, California, United States
Northridge, California, United States
Coral Springs, Florida, United States
Tampa, Florida, United States
Evanston, Illinois, United States
Oak Brook, Illinois, United States
Baltimore, Maryland, United States
Edina, Minnesota, United States
Kansas City, Missouri, United States
Lincoln, Nebraska, United States
Roseburg, Oregon, United States
Spartanburg, South Carolina, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Webster, Texas, United States
Salt Lake City, Utah, United States
Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Córdoba, , Argentina
Santa Fe, , Argentina
Brisbane, , Australia
Melbourne, , Australia
Melbourne, , Australia
Sydney, , Australia
Sydney, , Australia
Sydney, , Australia
Sydney, , Australia
Botucatu, , Brazil
Recife, , Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Copenhagen, , Denmark
Kolding, , Denmark
Odense, , Denmark
Bordeaux, Gironde, France
Créteil, , France
Grenoble, , France
Marseille, , France
Montpellier, , France
Saint Priest En Jarez, , France
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Auckland, , New Zealand
Hamilton, , New Zealand
Barcelona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Madrid, , Spain
Madrid, , Spain
Sevilla, , Spain
Sevilla, , Spain
Kaohsiung, , Taiwan
New Taipei City, , Taiwan
New Taipei City, , Taiwan
Taichung, , Taiwan
Taipei City, , Taiwan
Taipei, , Taiwan
Carshalton, , United Kingdom
Glasgow, , United Kingdom
Leicester, , United Kingdom
London, , United Kingdom
Salford, , United Kingdom
Prague, , Czechia
Shanghai, , China
Sydney, , Australia
Spartanburg, South Carolina, United States
Pathum Wan, , Thailand
Coral Gables, Florida, United States
Springfield, Massachusetts, United States
Paris, , France
Córdoba, , Spain
Madrid, , Spain
Madrid, , Spain
Charlotte, North Carolina, United States
Hualien City, , Taiwan
Melbourne, , Australia
Aachen, , Germany
São Paulo, , Brazil
Manchester, Greater Manchester, United Kingdom
Idaho Falls, Idaho, United States
Ipoh, , Malaysia
Suita, Osaka, Japan
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Loma Linda, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Oakland, California, United States
Sacramento, California, United States
San Diego, California, United States
Stanford, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
Miami, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Lawrenceville, Georgia, United States
Boise, Idaho, United States
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Chicago, Illinois, United States
Louisville, Kentucky, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Tupelo, Mississippi, United States
Kansas City, Missouri, United States
St. Louis, Missouri, United States
Hackensack, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
North Charleston, South Carolina, United States
Arlington, Texas, United States
El Paso, Texas, United States
Galveston, Texas, United States
Caba, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Brisbane, , Australia
Melbourne, , Australia
Melbourne, , Australia
Sydney, , Australia
Baotou, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Chengdu, , China
Chengdu, , China
Guangzhou, , China
Hangzhou, , China
Hangzhou, , China
Hohhot, , China
Jinan, , China
Nanchang, , China
Nanjing, , China
Shanghai, , China
Shenzhen, , China
Tianjin, , China
Yinchuan, , China
Zhanjiang, , China
Prague, , Czechia
La Roche Sur Yon, , France
Aachen, , Germany
Dresden, , Germany
Hamburg, , Germany
Hannover, , Germany
Hannover, , Germany
Koeln, , Germany
Luebeck, , Germany
Mainz, , Germany
Villingen Schwenningen, , Germany
Bari, , Italy
Bologna, , Italy
Genova, , Italy
Milano, , Italy
Pavia, , Italy
Roma, , Italy
Torino, , Italy
Kasugai, Aichi, Japan
Toyoake, Aichi, Japan
Ichihara, Chiba, Japan
Higashi, Fukuoka, Japan
Yokohama, Fukuura, Japan
Asahikawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kobe, Hyogo, Japan
Sendai, Miyagi, Japan
Kashihara, Nara, Japan
Kitaku, Okayama, Japan
Suita, Osaka, Japan
Kawagoe, Saitama, Japan
Tokushima City, Tokushima, Japan
Showa Ku, Tsurumaicho, Japan
Ube, Yamaguchi, Japan
Chiba, , Japan
Kyoto, , Japan
Osaka, , Japan
Tokyo, , Japan
Kajang, Selangor, Malaysia
Cheras, , Malaysia
Ipoh, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Lumpur, , Malaysia
Kuantan, , Malaysia
Petaling Jaya, , Malaysia
Aguascalientes, , Mexico
Chihuahua, , Mexico
Culiacan, , Mexico
Guadalajara, , Mexico
Monterrey, , Mexico
Dunedin, , New Zealand
Braga, , Portugal
Carnaxide, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Loures, , Portugal
Porto, , Portugal
Setúbal, , Portugal
Vila Franca De Xira, , Portugal
Vila Nova De Gaia, , Portugal
Almeria, , Spain
Barcelona, , Spain
Majadahonda, , Spain
Hualien City, , Taiwan
Tainan, , Taiwan
Bangkoknoi, , Thailand
Bangkok, , Thailand
Chiangmai, , Thailand
Hat Yai, , Thailand
Khon Kaen, , Thailand
Pathum Wan, , Thailand
Ankara, , Turkey
Ankara, , Turkey
Antalya, , Turkey
Bursa, , Turkey
Edirne, , Turkey
Erciyes, , Turkey
Istanbul, , Turkey
Kocaeli, , Turkey
Birmingham, , United Kingdom
Bristol, , United Kingdom
Canterbury, , United Kingdom
Coventry, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Manchester, , United Kingdom
Nottingham, , United Kingdom
Sheffield, , United Kingdom
Stevenage, , United Kingdom
Phoenix, Arizona, United States
Northridge, California, United States
Stanford, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
Coral Springs, Florida, United States
Orlando, Florida, United States
Boise, Idaho, United States
Oak Brook, Illinois, United States
Tupelo, Mississippi, United States
Kansas City, Missouri, United States
Philadelphia, Pennsylvania, United States
North Charleston, South Carolina, United States
El Paso, Texas, United States
Houston, Texas, United States
Buenos Aires, , Argentina
Caba, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Córdoba, , Argentina
Santa Fe, , Argentina
Brisbane, , Australia
Botucatu, , Brazil
Recife, , Brazil
Rio De Janeiro, , Brazil
Bordeaux, Gironde, France
Grenoble, , France
Montpellier, , France
Saint Priest En Jarez, , France
Hannover, , Germany
Luebeck, , Germany
Villingen Schwenningen, , Germany
Ichihara, Chiba, Japan
Yokohama, Fukuura, Japan
Asahikawa, Hokkaido, Japan
Kashihara, Nara, Japan
Kitaku, Okayama, Japan
Tokushima City, Tokushima, Japan
Showa Ku, Tsurumaicho, Japan
Chiba, , Japan
Cheras, , Malaysia
Chihuahua, , Mexico
Culiacan, , Mexico
Monterrey, , Mexico
Braga, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Loures, , Portugal
Porto, , Portugal
Setúbal, , Portugal
Vila Franca De Xira, , Portugal
Vila Nova De Gaia, , Portugal
Almeria, , Spain
New Taipei City, , Taiwan
Chiangmai, , Thailand
Antalya, , Turkey
Erciyes, , Turkey
Carshalton, , United Kingdom
Manchester, , United Kingdom
Salford, , United Kingdom
Patients applied
Trial Officials
David Fuller
Study Director
Dimerix Bioscience Pty Ltd
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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