A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
ConditionFSGS
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-80
SponsorDimerix Bioscience Pty Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must be 12 to 80 years old
A diagnosis of primary FSGS, genetic FSGS, or FSGS of undetermined cause. Confirmed by kidney biopsy within 7 years of screening
Must be either receiving an ARB at the maximal tolerated dose or willing to transition
If taking corticosteroids, the dosage must be stable for ≥4 weeks prior to Screening and during Stabilization
Disqualifiers
Has FSGS secondary to another condition.
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).
History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin [HbA1c] >8% at Screening)
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).
Trial design
Design model
Parallel
Treatments tested in this trial
DMX-200
DrugDMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor.
Placebo
DrugPatients will receive 120 mg capsules of Placebo twice daily
Treatment groups
286 Participants
are divided into 2 treatment groupsGroup A: DMX-200 (repagermanium)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Baseline to Week 352
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 eGFR
Time frame
Baseline to Week 1043
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.
Time frame
Double-blind baseline to Week 216Secondary outcomes
1
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.
Time frame
Baseline to Week 1042
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.
Time frame
Baseline to Week 1043
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
Time frame
From Week 108 (Baseline) at each visit4
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.
Time frame
Double blind baseline to Week 216Sponsors and contacts
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Source ClinicalTrials.gov