OverviewStudy detailsEligibilityThings to knowResearchStudy plan
info
Simplify with AI

A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB

PHASE3RECRUITING

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE3

trial

Study ID

NCT05183646

Intervention or treatment

DRUG: DMX-200

DRUG: Placebo

Conditions

  • FSGS

  • Condition: FSGS

  • DRUG: DMX-200 and other drugs

  • Brisbane, Australia and more

  • Sponsor: Dimerix Bioscience Pty Ltd

Save

Share

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Griffith University

Select from list below to view details:

  • Griffith University

    Brisbane, Australia

  • Princess Alexandra Hospital

    Brisbane, Australia

  • Austin Hospital

    Melbourne, Australia

  • Monash Health

    Melbourne, Australia

Loading map...

Who is running the clinical trial?

DBPL

Dimerix Bioscience Pty Ltd

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: DMX-200 (repagermanium)
  • 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)
Drug: DMX-200
    PLACEBO_COMPARATOR: Placebo
    • Patients will receive 120 mg immediate release capsules of Placebo twice daily
    Drug: Placebo

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      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)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 eGFRBaseline 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.Double-blind baseline to Week 216

      Secondary Outcome

      MeasureDescriptionTime Frame
      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.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.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 PCRFrom 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.Double blind baseline to Week 216
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB

      Other trials to consider

      Loading suggested trials...

      Top searched conditions

      Breast CancerLung CancerType 2 DiabetesDermatitisAlzheimersParkinsonsLupusCrohn’s DiseaseAsthmaHypertensionCOPDMultiple SclerosisOsteoarthritisHIV/AIDSPsoriasisStrokeObesityProstate CancerDepressionCardiovascular