Actively Recruiting
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
Led by Dimerix Bioscience Pty Ltd · Updated on 2026-02-03
286
Participants Needed
220
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating DMX-200 repagermanium, a drug that blocks a receptor involved in inflammation, in patients with focal segmental glomerulosclerosis FSGS who are also receiving an angiotensin II receptor blocker ARB. This Phase 3 study aims to assess the safety and effectiveness of DMX-200 compared to placebo over two years in adults and adolescents aged 12 to 17 years. The study is led by Dimerix Bioscience Pty Ltd and includes a double-blind period followed by an open-label extension to observe long-term effects. Participants receive either 120 mg of DMX-200 or a matching placebo capsule twice daily for 104 weeks during the double-blind treatment phase. Afterward, those who complete this phase may enter a two-year open-label extension where all participants receive DMX-200 twice daily. The study includes a screening and qualification period lasting 6 to 14 weeks, a possible titration phase, a stabilization phase, and a follow-up period after treatments. Throughout the trial, patients will undergo assessments including urine proteincreatinine ratio and kidney function tests like estimated glomerular filtration rate eGFR at multiple time points up to week 104 and during the extension. Safety and tolerability are closely monitored through regular evaluations, adverse event tracking, and follow-up visits. Total participation may last about 230 weeks, covering all study phases and follow-up periods.
CONDITIONS
Brief Title
A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 to 80 years
- Diagnosis of primary, genetic, or undetermined cause FSGS confirmed by kidney biopsy within 7 years
- Receiving an ARB at maximal tolerated dose or willing to transition
- Stable corticosteroid dosage for at least 4 weeks prior to screening and during stabilization if applicable
- Stable doses of aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, SGLT2 inhibitors, or endothelin receptor antagonists for at least 12 weeks prior to screening and during stabilization if applicable
- Urine protein/creatinine ratio >1.5 g/g or 24-hour total protein >1.5 g/day during screening
- Estimated eGFR ≥25 and ≤120 mL/min/1.73 m2 for adults; ≥25 mL/min/1.73 m2 for adolescents
- Seated blood pressure ≤160/100 mm Hg for adults or within 5th to 95th percentile for age, sex, and height for adolescents
- Body weight ≥35 kg and BMI ≤40 kg/m2 for adults or between 5th and 98th percentile for age and sex for adolescents
- Female patients must not be pregnant or breastfeeding and must meet contraception requirements if of childbearing potential
- Male patients with female partners of childbearing potential must agree to use acceptable contraception
- Capable of giving informed consent or assent as appropriate
You will not qualify if you...
- FSGS secondary to another condition
- Nephrotic syndrome (>3.5 g/day proteinuria and serum albumin <30 g/L) untreated with standard FSGS therapies
- History of type 1 diabetes or uncontrolled type 2 diabetes (HbA1c >8%)
- History of lymphoma, leukemia, or active malignancy within past 2 years (except certain skin or cervical cancers)
- Active significant liver or biliary disease
- History of severe heart failure or recent major cardiac events
- Any condition interfering with study evaluation as judged by investigator
- History of alcohol or drug use disorder within 1 year prior to screening
- Previous organ or stem cell transplant (except corneal transplant)
- Positive tests for hepatitis B, hepatitis C with RNA, or HIV
- High serum potassium (>5.5 mmol/L)
- Elevated liver enzymes (ALT and AST >2 times upper limit of normal)
- Recent treatment with non-steroid immunosuppressants including biologics within 12 weeks
- Allergic reaction or sensitivity to angiotensin II antagonists or study drug components
- Unable to swallow oral medication
- Prior participation in DMX-200 studies
- Participation in other investigational studies within 28 days or 5 half-lives prior to screening
- Study site personnel or immediate family members involved in this study
Research Team
D
David Fuller
A
Alisha Smith
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