focal segmental glomerulosclerosis (FSGS)
Conditions
Interventions
Patients will take DMX-200 as 120 mg powder-in-capsules or matching placebo BID over a treatment period of up to 104 weeks during the double-blind period. During the OLE period, all patients will take
Sponsors
Fuller David
FUSO Pharmaceutical Industries, Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Primary FSGS, genetic FSGS, or FSGS of undetermined cause (FSGS-UC) diagnosed within 7 years of screening. -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=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 =18 years of age) at Screening. -Body weight >=35 kg (all patients) AND a body mass index (BMI) =18 years of age) or 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.
Exclusion criteria
Exclusion criteria: -Has FSGS secondary to another condition. -Patients with nephrotic syndrome (>3.5 g/day proteinuria and serum albumin 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Percent change in urine PCR (based on 24-hour urine collection) from Baseline to Week 35 following treatment with DMX-200 compared with placebo -Slope of eGFR from Baseline to Week 104 following treatment with DMX-200 compared with placebo | — |
Countries
ARGENTINA, AUSTRALIA, BRAZIL, CHINA, CZECH REP, DENMARK, FRANCE, GERMANY, HONG KONG, ITALY, Japan, MALAYSIA, MEXICO, NEW ZEALAND, PORTUGAL, SPAIN, TAIWAN, THAILAND, TURKEY, UK, USA
Contacts
Public ContactjRCT Inquiry Contact
IQVIA Services Japan G.K.
Outcome results
None listed