Dapagliflozin for Membranous nephropathy

Inclusion criteria

• {"criterion_text":"- Participants ≥ 18 years old and < 85 years old\n- Membranous Nephropathy associated with anti-PLA2R1 autoantibodies\n- Urine Protein Creatinine Ratio (UPCR) between 0.5 g/g and 3.5 g/g\n- Immunological relapse defined by an increase in anti-PLA2R1 antibody concentration > 14 RU/mL after a phase of immunological and clinical remission\n- Antiproteinuric treatment at maximal and stable dose"}

Exclusion criteria

• {"criterion_text":"- Immunosuppressive treatment for MN in the 6 months prior to the selection visit\n- NYHA functional class IV heart failure\n- Patients already currently receiving dapagliflozin or another SGLT2 inhibitor for another condition\n- Repeated urinary tract infections\n- Hypersensitivity to the active substance or excipients\n- Secondary MN (associated with cancer, infectious disease, autoimmune or iatrogenic disease);\n- Active nephrotic syndrome defined according to KDIGO guidelines as proteinuria > 3.5 g/day (or 3.5 g/g in a urine sample) and albumin < 30 g/L\n- No previous history of immunological remission (anti-PLA2R1 antibodies < 14 RU/mL in ELISA or negative indirect immunofluorescence) or clinical remission (partial or complete)\n- Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption disorders\n- Type 1 diabetes\n- Pregnancy or breastfeeding\n- Estimated CKD-EPI Glomerular Filtration Rate (eGFR) < 25 ml/min/1.73m2\n- Severe liver failure (Child-Pugh stage C)"}

Primary endpoints

• {"endpoint_text":"- Change in anti-PLA2R1 antibody titer (ELISA titer in RU/mL) from baseline to 6 months after dapagliflozin treatment compared with pretreatment antibody titer","definition_or_measurement_approach":"Measured by ELISA titer in RU/mL comparing baseline to 6 months after dapagliflozin treatment."}

Secondary endpoints

• {"endpoint_text":"- Change in proteinuria (in g/g) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment)","definition_or_measurement_approach":"Change in urine protein/creatinine ratio (g/g) from baseline to 6 months under stable antiproteinuric therapy."}
• {"endpoint_text":"- Change in albumin levels (in g/L) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment)","definition_or_measurement_approach":"Change in serum albumin (g/L) from baseline to 6 months under stable antiproteinuric therapy."}
• {"endpoint_text":"- Change in glomerular filtration rate (in ml/min/1.73m2) from baseline to 6 months after dapagliflozin treatment (under stable antiproteinuric treatment)","definition_or_measurement_approach":"Change in estimated GFR (ml/min/1.73m2) from baseline to 6 months under stable antiproteinuric therapy."}
• {"endpoint_text":"- Need for Rituximab treatment for clinical relapse (according to KDIGO 2021 guidelines and French 2022 guidelines)","definition_or_measurement_approach":"Occurrence of requirement for Rituximab for clinical relapse as defined by KDIGO 2021 and French 2022 guidelines."}
• {"endpoint_text":"- Change in cytokine profile from baseline to 6 months after dapagliflozin treatment (analysis of 9 cytokines: IL-12p70; IL-17A; IL-4; IL-5; IL-1β; IL-10; IFNα; IL-6 and IFNγ)","definition_or_measurement_approach":"Measurement of specified cytokine concentrations at baseline and 6 months; analysis of changes in levels of IL-12p70, IL-17A, IL-4, IL-5, IL-1β, IL-10, IFNα, IL-6 and IFNγ."}
• {"endpoint_text":"- Clinical and biological tolerance of dapagliflozin treatment","definition_or_measurement_approach":"Assessed by monitoring occurrence of clinical symptoms and biological safety parameters during treatment."}

France

Earliest CTIS Part Ii Submission Date

05-06-2025

Latest Decision Or Authorization Date

15-07-2025

Processing Time Days

40

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nice

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France