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Evaluating DMX-200 for treating FSGS in patients on ARBs

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)

Phase 3 Interventional Dimerix Bioscience Pty Ltd · NCT05183646

This study is testing if a new medication called DMX-200 can help people with FSGS who are already taking another heart medication feel better and improve their kidney function.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment286 (estimated)
Ages12 Years to 80 Years
SexAll
SponsorDimerix Bioscience Pty Ltd Industry-sponsored
Drugs / interventionsrituximab, cyclophosphamide
Locations220 sites (Birmingham, Alabama and 219 other locations)
Trial IDNCT05183646 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial investigates the efficacy and safety of DMX-200, a CCR2 inhibitor, in patients with FSGS who are concurrently receiving an angiotensin receptor blocker (ARB). The study is designed as a randomized, double-blind, placebo-controlled trial lasting up to 122 weeks, followed by an open-label extension period of up to 2 additional years. Participants aged 12 to 80 years with confirmed FSGS will be enrolled, and the trial aims to assess the impact of DMX-200 on proteinuria and kidney function. The study includes a comprehensive screening and stabilization phase to ensure patient eligibility and safety.

Who should consider this trial

Good fit: Ideal candidates are patients aged 12 to 80 years diagnosed with primary or genetic FSGS who are currently on or willing to transition to an ARB.

Not a fit: Patients with stable doses of certain medications or those with severe kidney impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and reduce proteinuria in patients with FSGS.

How similar studies have performed: Other studies have shown promise with CCR2 inhibitors in similar conditions, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 219 other locations

+170 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions FSGSfsgsfocal segmental glomerulosclerosiskidney disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.