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A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
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
Exclusion criteria
Eligibility
Age eligible for study : 12 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-05-30
Primary completion: 2024-06-01
Study completion finish: 2026-06-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05183646
Intervention or treatment
DRUG: DMX-200
DRUG: Placebo
Conditions
- • FSGS
Find a site
Closest Location:
ACTION3 Investigational Site 1
Research sites nearby
Select from list below to view details:
ACTION3 Investigational Site 1
Brisbane, Not Specified, Australia
ACTION3 Investigational Site 2
Melbourne, Not Specified, Australia
Action3 Investigator Site 6
Melbourne, Not Specified, Australia
ACTION3 Investigational Site 4
Sydney, Not Specified, Australia
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/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: DMX-200 (repagermanium)
| DRUG: DMX-200
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Evaluate the efficacy of DMX-200 in terms of urine 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 eGFR slope in patients with FSGS who are receiving an ARB (Analysis at week 35 and Week 104). | Slope of eGFR | Baseline 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 AEs and any AESIs and SAEs following long-term treatment with DMX-200. | Double-blind baseline to Week 216 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Evaluate the incidence and severity of AEs with treatment of DMX-200 in 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 PCR | From 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 |
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