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CCR2 Inhibitor

DMX-200 for Focal Segmental Glomerulosclerosis (ACTION3 Trial)

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
A diagnosis of FSGS confirmed by kidney biopsy or documentation of a genetic mutation in a podocyte protein associated with FSGS
Must be either receiving an ARB at the maximal tolerated dose or willing to transition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 104
Awards & highlights

ACTION3 Trial Summary

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

Who is the study for?
Adults with FSGS (a kidney disease) confirmed by biopsy or genetic testing, who are not breastfeeding, have a BMI ≤40 kg/m2, and are on stable doses of certain medications can join. They must be taking or agree to take an ARB at the highest dose they can handle. Those with serious side effects to angiotensin II antagonists, recent drug abuse, organ transplants (except corneal), heart failure, or conditions that could affect study results cannot participate.Check my eligibility
What is being tested?
The trial is testing DMX-200's effectiveness and safety in treating FSGS when taken alongside an ARB medication. Participants will either receive DMX-200 or a placebo twice daily for 104 weeks in this randomized double-blind study where neither the participants nor the researchers know who gets which treatment until after the study ends.See study design
What are the potential side effects?
Possible side effects include those related to CCR2 inhibitors like DMX-200 such as immune system changes leading to increased infection risk and potential allergic reactions. The exact side effects aren't listed but typically involve monitoring for any new symptoms that arise during treatment.

ACTION3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My FSGS diagnosis was confirmed by a kidney biopsy or genetic test.
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I am taking the highest dose of ARB I can tolerate or am willing to start.
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My medication doses for certain heart or diabetes drugs have been stable for the last 12 weeks.

ACTION3 Trial Timeline

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

ACTION3 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

Find a Location

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
Ash SomanStudy DirectorDimerix Bioscience Pty Ltd
Robert ShepherdStudy DirectorDimerix Bioscience Pty Ltd

Media Library

DMX-200 (CCR2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05183646 — Phase 3
Focal Segmental Glomerulosclerosis Research Study Groups: Placebo, DMX-200 (repagermanium)
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

Who else is applying?

What state do they live in?
Minnesota
Illinois
What site did they apply to?
Other
ACTION3 Investigational Site 4
ACTION3 Investigational Site 15
ACTION 3 Investigator Site 19
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

Improve kidney disease research. I'm in stage 3 and I thought maybe there was a way to reverse this.
PatientReceived 2+ prior treatments
I really need the money and I want to help people while doing so if possible.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. ACTION 3 Investigator Site 19: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
2022. "A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05183646.
~12 spots leftby Jun 2024
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