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Efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis
EU CTIS ID: 2023-504597-37-00
What this study is testing
To evaluate the efficacy of DMX-200 in terms of urine PCR and eGFR slope in adult patients with FSGS who are receiving an ARB. OLE: To assess the long-term safety and tolerability of open-label treatment with DMX-200 in patients with FSGS who are receiving an ARB.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Primary FSGS, genetic FSGS, or FSGS of undetermined cause (FSGS-UC) with timing of initial diagnosis within 7 years prior to screening. NOTE: i) Primary FSGS and FSGS-UC, the initial diagnosis must be biopsy-proven within 7 years prior to Screening. The kidney biopsy could have been obtained at any time within the previous 7 years and should be based on light microscopy with supportive findings on either electron microscopy or immunofluorescence. ii) For Genetic FSGS, no biopsy is required where there is a documented genetic mutation of a podocyte protein associated with FSGS. The genetic testing should have been obtained within 7 years prior to screening. iii) All patients should demonstrate a clinical history and disease course consistent with FSGS.
- OLE: The patient received blinded IP throughout the duration of the double-blind period up to the Week 104 (EOT – DB) visit (ie, did not prematurely and permanently discontinue the IP).
- Must be either receiving an ARB at the maximal tolerated dose and ≥ 50% of the maximum recommended dose per the product label prior to Screening, or willing to transition to this treatment (including transition from an ACE inhibitor) prior to stabilization
- If taking corticosteroids, the dosage must be ≤ 10mg / day prednisone (or equivalent) and stable for ≥4 weeks prior to and during both Screening and Stabilization, and there must be no plan to change their corticosteroid treatment regimen during study. Use of inhaled corticosteroids for respiratory diseases is allowed.
- If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, sodium-glucose co-transporter-2 inhibitors, or endothelin receptor antagonists (including dual antagonists), the dose and regimen must be stable for ≥12 weeks prior to Screening and maintained during Stabilization and patients must have no plan to change their treatment regimen during the study
- Urine protein/creatinine ratio (PCR) >1.5 g/g (>169.5 mg/mmol) or 24-hour total protein >1.5 g/day based on 24-hour urine collection during Screening and Qualification
You likely can't join if
- Has FSGS secondary to another condition
- OLE: The patient has met the criteria for premature and permanent IP discontinuation as defined in Section 7.1 or study discontinuation as defined in Section 7.2 at Week 104, or prior to the first open-label dose of DMX 200 at Week 108.
- 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).
- OLE: Any safety concerns identified during the double-blind period which, in the Investigator’s opinion, may interfere with the patient’s continued participation during the OLE period.
- History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin >8%)
- 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)
See the full eligibility criteria
Who can join
- Primary FSGS, genetic FSGS, or FSGS of undetermined cause (FSGS-UC) with timing of initial diagnosis within 7 years prior to screening. NOTE: i) Primary FSGS and FSGS-UC, the initial diagnosis must be biopsy-proven within 7 years prior to Screening. The kidney biopsy could have been obtained at any time within the previous 7 years and should be based on light microscopy with supportive findings on either electron microscopy or immunofluorescence. ii) For Genetic FSGS, no biopsy is required where there is a documented genetic mutation of a podocyte protein associated with FSGS. The genetic testing should have been obtained within 7 years prior to screening. iii) All patients should demonstrate a clinical history and disease course consistent with FSGS.
- OLE: The patient received blinded IP throughout the duration of the double-blind period up to the Week 104 (EOT – DB) visit (ie, did not prematurely and permanently discontinue the IP).
- Must be either receiving an ARB at the maximal tolerated dose and ≥ 50% of the maximum recommended dose per the product label prior to Screening, or willing to transition to this treatment (including transition from an ACE inhibitor) prior to stabilization
- If taking corticosteroids, the dosage must be ≤ 10mg / day prednisone (or equivalent) and stable for ≥4 weeks prior to and during both Screening and Stabilization, and there must be no plan to change their corticosteroid treatment regimen during study. Use of inhaled corticosteroids for respiratory diseases is allowed.
- If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, sodium-glucose co-transporter-2 inhibitors, or endothelin receptor antagonists (including dual antagonists), the dose and regimen must be stable for ≥12 weeks prior to Screening and maintained during Stabilization and patients must have no plan to change their treatment regimen during the study
- Urine protein/creatinine ratio (PCR) >1.5 g/g (>169.5 mg/mmol) or 24-hour total protein >1.5 g/day based on 24-hour urine collection during Screening and Qualification
- Estimated glomerular filtration rate (eGFR) at screening: For adults (≥ 18 years): eGFR ≥25 and ≤120 mL/min/1.73 m2 using the CKD Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2009) For adolescent patients (<18): eGFR ≥25mL/min/1.73 m2using the Modified Schwartz formula
- Seated blood pressure ≤160/100 mm Hg (mean of 3 values) (patients ≥18 years of age) or between the 5th and 95th percentile for age, sex, and height (patients <18 years of age) at Screening
- Body weight ≥35 kg (all patients) AND a body mass index (BMI) ≤40 kg/m2 (patients ≥18 years of age) or between the 5th and 98th percentile for age and sex (patients <18 years of age) at Screening. For patients with moderate or severe edema, BMI will be calculated based on remission or premorbid weight measured within 3 months prior to Screening, if available. If not available, BMI will be calculated based on the estimated dry weight, based on the Investigator’s clinical judgment
- OLE: Patients who have completed participation in the double-blind period, including the Week 104 visit (including non-responders, those with disease worsening, and those receiving additional FSGS-directed therapies)
What rules you out
- Has FSGS secondary to another condition
- OLE: The patient has met the criteria for premature and permanent IP discontinuation as defined in Section 7.1 or study discontinuation as defined in Section 7.2 at Week 104, or prior to the first open-label dose of DMX 200 at Week 108.
- 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).
- OLE: Any safety concerns identified during the double-blind period which, in the Investigator’s opinion, may interfere with the patient’s continued participation during the OLE period.
- History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin >8%)
- 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)
- Active clinically significant hepatobiliary disease
- Documented history of heart failure (New York Heart Association Class III/IV) or a major adverse cardiac event within 12 weeks prior to Screening
- Serum potassium levels >5.5 mmol/L at Screening
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 × upper limit of normal at Screening
- Received any of the following with the specified timeframe prior to Screening - Treatment with non-steroid immunosuppressant agents including biological drugs (eg. rituximab), calcineurin inhibitors, cyclophosphamide, azathioprine, or mycophenolate mofetil within 12 weeks prior to Screening
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Hong Kong
- Thailand
- United Kingdom
- China
- Malaysia
- Australia
- Taiwan
- United States
- Japan
- Mexico
- New Zealand
- Turkey
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Hong Kong; Thailand; United Kingdom; China; Malaysia and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.