Efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis
- Conditions
- Focal segmental glomerulosclerosisMedDRA version: 21.1Level: PTClassification code 10067757Term: Focal segmental glomerulosclerosisSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 21.1Level: LLTClassification code 10016832Term: Focal & segmental glomerulosclerosisSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-004174-64-ES
- Lead Sponsor
- Dimerix Bioscience Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 286
Key Inclusion Criteria:
- A diagnosis of FSGS confirmed by kidney biopsy. NOTE: The biopsy can have been obtained at any time. Diagnosis of FSGS should be based on light microscopy with supportive findings on either electron microscopy or immunofluorescence analysis (preferably both) and the clinical history and disease course consistent with primary FSGS, genetic FSGS, or FSGS of undetermined cause.
- Must be receiving a stable dose of an ARB (irbesartan, losartan, valsartan, candesartan, olmesartan medoxomil, or azilsartan medoxomil) at the maximal tolerated dose and =50% of the maximum recommended dose per the product label for 6 weeks prior to Screening, or willing to transition to this treatment during the Titration and Stabilization period.
- If taking corticosteroids, the dosage must be stable for =4 weeks prior to Screening and during the Stabilization period, and patients must have no plan to change their treatment regimen during the study.
- If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, or sodium-glucose co-transporter-2 inhibitors, the dose and regimen must be stable for =26 weeks prior to Screening and during the Stabilization period 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.
- Estimated glomerular filtration rate (eGFR) =30 mL/min/1.73 m2 at Screening and =25 mL/min/1.73 m2 at the Qualification visit (Week -1).
- Seated blood pressure =160/100 mm Hg (mean of 3 values) at Screening and =140/90 mm Hg (mean of 3 values) at the Qualification visit (Week -1).
- Body mass index =40 kg/m2 at Screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 263
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23
Key Exclusion Criteria:
- Has FSGS secondary to another condition.
- History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin >8%), or non-fasting blood glucose >10 mmol/L 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).
- History of jaundice, active hepatitis, or known hepatobiliary disease (except asymptomatic cholelithiasis).
- 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.
- Treatment with immunosuppressant biological drugs, calcineurin inhibitors, cyclophosphamide, azathioprine, or mycophenolate mofetil within 26 weeks prior to Screening
- Patients with <80.0% compliance to ARB treatment during the Stabilization Period (Weeks -6 to -1) of the study, as confirmed at the Qualification visit.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of DMX-200 in terms of urine PCR and eGFR slope in patients with FSGS who are receiving an ARB;Secondary Objective: - To evaluate the safety and tolerability of treatment with DMX-200 in patients with FSGS who are receiving an ARB<br>- To evaluate the effect of DMX-200 on kidney function parameters including proteinuria in patients with FSGS who are receiving an ARB;Primary end point(s): 1. Percent change in urine PCR (based on 24-hour urine collection) following treatment with DMX-200 compared with placebo<br>2. Slope of eGFR following treatment with DMX-200 compared with placebo;Timepoint(s) of evaluation of this end point: 1. from Baseline to Week 35 <br>2. from Baseline to Week 104
- Secondary Outcome Measures
Name Time Method