What side effects are associated with this type of intervention?

Common treatments for Focal Segmental Glomerulosclerosis (FSGS) include corticosteroids, calcineurin inhibitors (like cyclosporine and tacrolimus), and immunosuppressive agents (such as cyclophosphamide). Known side effects of these treatments can include increased risk of infections, hypertension, nephrotoxicity, hyperglycemia, gastrointestinal disturbances, and bone marrow suppression. For treatments similar to DMX-200, which is a CCR2 inhibitor, potential side effects may include gastrointestinal issues, fatigue, and increased risk of infections, although specific side effect profiles for CCR2 inhibitors in FSGS are still being studied.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically targeting CCR2 inhibitors for Focal Segmental Glomerulosclerosis (FSGS). The current standard treatments for FSGS often include corticosteroids, calcineurin inhibitors (such as cyclosporine and tacrolimus), and other immunosuppressive agents. These treatments aim to reduce proteinuria and slow disease progression. DMX-200 (repagermanium) is being studied as a novel approach by inhibiting CCR2 to reduce inflammation and monocyte recruitment, which is a different mechanism compared to the existing therapies.

What other types of research exist?

Promising alternatives to DMX-200 for FSGS patients include Rituximab, which targets B-cells and has shown efficacy in autoimmune kidney diseases, and Mycophenolate Mofetil, an immunosuppressant used in various glomerular diseases. Additionally, SGLT2 inhibitors like Empagliflozin, which have shown benefits in diabetic nephropathy, may offer potential benefits due to their renal protective effects.

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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 double blind baseline to week 216

Awards & highlights

Pivotal Trial

Summary

This trial is testing DMX-200, a drug designed to reduce inflammation by blocking signals that attract immune cells. It targets adult patients with a specific kidney disease called FSGS. The drug works by preventing immune cells from gathering in the kidneys, which may help slow down the disease.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ double-blind baseline to week 216

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~double-blind baseline to week 216

This trial's timeline: 3 weeks for screening, Varies for treatment, and double-blind baseline to week 216 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

OLE - Assess the long-term safety and tolerability of open-label treatment with DMX-200 in patients with FSGS who are receiving an ARB.

Secondary study objectives

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

OLE - Assess the long-term efficacy of open-label treatment with DMX-200 in patients with FSGS who are receiving an ARB.

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.

+1 more

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) OLE: Patients will receive 120 mg immediate release capsules of DMX-200 twice daily during the OLE period (108-212 weeks)

Group II: PlaceboPlacebo Group1 Intervention

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Focal Segmental Glomerulosclerosis (FSGS) include CCR2 inhibitors like DMX-200, which work by inhibiting the recruitment of monocytes that contribute to inflammation and kidney damage. This is crucial for FSGS patients as it helps reduce the inflammatory response and subsequent glomerular injury. Other treatments include immunosuppressive therapies, such as corticosteroids and cyclophosphamide, which reduce immune system activity to prevent further kidney damage. Rho-kinase inhibitors, like fasudil, alleviate glomerular injury by reducing mesangial proliferation and extracellular matrix accumulation. These mechanisms are vital for managing FSGS as they target the underlying processes that lead to kidney damage and progression of the disease.

CCR2- and CCR5-mediated macrophage infiltration contributes to glomerular endocapillary hypercellularity in antibody-induced lupus nephritis.A Rho-kinase inhibitor, fasudil, attenuates progressive glomerulosclerosis induced by daunorubicin in rats.Increased 5-lipoxygenase activating protein in immune-mediated experimental nephritis.