CCR2 Inhibitor

DMX-200 for Focal Segmental Glomerulosclerosis

Verified Trial

Phase 3

Recruiting

Research Sponsored by Dimerix Bioscience Pty Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, or sodium-glucose co-transporter-2 (SGLT2) inhibitors, the dose and regimen must be stable for ≥12 weeks prior to Screening and during Stablization

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline to week 104

Awards & highlights

Pivotal Trial

Study Summary

This trial is investigating whether a drug called DMX-200 can help treat patients with a kidney disease called FSGS.

Eligible Conditions

Focal Segmental Glomerulosclerosis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

If you are taking certain medications like aldosterone inhibitors, your dosage and routine must remain stable for at least 12 weeks before and during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the efficacy of DMX-200 in terms of eGFR slope in patients with FSGS who are receiving an ARB (Analysis at week 35 and Week 104)

Evaluate the efficacy of DMX-200 in terms of urine PCR in patients with FSGS who are receiving an ARB

Secondary outcome measures

Evaluate the effect of DMX-200 on kidney function parameters as defined by the onset of kidney failure, a 30% decline in eGFR from Baseline, or death from kidney or cardiovascular causes in patients with FSGS who are receiving an ARB

Evaluate the incidence and severity of AEs with treatment of DMX-200 in patients with FSGS who are receiving an ARB

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DMX-200 (repagermanium)Experimental Treatment1 Intervention

Patients will receive 120 mg immediate release capsules of DMX-200 twice daily during the treatment period (104 weeks)

Group II: PlaceboPlacebo Group1 Intervention

Patients will receive 120 mg immediate release capsules of Placebo twice daily

0 / 1Eligibility criteria met

Find a site

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Dimerix Bioscience Pty LtdLead Sponsor

2 Previous Clinical Trials

53 Total Patients Enrolled

Robert ShepherdStudy Director

Dimerix Bioscience Pty Ltd

Ash SomanStudy Director

Dimerix Bioscience Pty Ltd

Media Library

DMX-200 (CCR2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05183646 — Phase 3

Focal Segmental Glomerulosclerosis Research Study Groups: DMX-200 (repagermanium), Placebo

Focal Segmental Glomerulosclerosis Clinical Trial 2023: DMX-200 Highlights & Side Effects. Trial Name: NCT05183646 — Phase 3

DMX-200 (CCR2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05183646 — Phase 3

Focal Segmental Glomerulosclerosis Patient Testimony for trial: Trial Name: NCT05183646 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients being taken in for this clinical trial right now?

"That is correct, the online information from clinicaltrials.gov affirms that this trial is still looking for participants. The posting date was May 30th, 2022, and it was last updated on July 21st of the same year. They are expecting to have 286 patients total from 18 different hospitals or clinics."

Answered by AI

How many people are being given the opportunity to participate in this trial?

"To conduct this study, we need 286 participants who meet the pre-specified inclusion criteria. These individuals can enroll at one of many clinical sites such as ACTION3 Investigational Site 4 in Phoenix, Arizona or ACTION3 Investigational site 10 located in Northridge, California."

Answered by AI

What are the potential side effects of DMX-200?

"DMX-200 has been found to be safe in multiple rounds of testing and has some efficacy data, so it received a score of 3."

Answered by AI

Does this experiment only accept people below a certain age?

"Eligibility for this clinical trial is restricted to individuals that are aged 18-80. If you are under 18 or over 65, there 1 and 4 trials you might be eligible for respectively."

Answered by AI

If I meet the qualifications, may I sign up for this research project?

"This study is looking for 286 participants aged 18-80 who have FSGS. The following criteria must also be met: · Patients must be 18 to 80 years old · If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, or sodium-glucose co-transporter-2 (SGLT2) inhibitors, the dose and regimen must be stable for ≥12 weeks prior to Screening · Urine PCR >1.5 g/g (>169.5 mg/mmol) or 24-hour total protein >1.5 g"

Answered by AI

Are the research sites for this trial widely dispersed geographically?

"To make travelling for this trial as easy as possible on participants, the team has set up 18 enrolment sites. You can find these in Phoenix, Northridge, Baltimore and other cities."

Answered by AI