Interferon Alfa Therapy Based on Th17 Profile in Membranous Nephropathy (ALPHAGEM)
Membranous Nephropathy
About this trial
This is an interventional treatment trial for Membranous Nephropathy focused on measuring Membranous nephropathy, Immunomodulatory therapy, Interferon alpha, Interleukine 17-A (IL-17A), Personalized medicine
Eligibility Criteria
Inclusion Criteria: Age 18 and above Diagnosis of membranous nephropathy PLA2R1 antibodies-mediated Immunological relapse (defined as an increase in anti-PLA2R1 antibody titer > 14 RU/mL after a phase of anti-PLA2R1 antibody negativation, i.e. immunological remission) Plasma IL-17A levels > 73 pg/mL after non-specific stimulation of peripheral blood immune cells Symptomatic anti-proteinuric treatment at a stable, maximum-tolerated dosage; Patients with: (i) a platelet count≥ 90,000 cells/mm3; (ii) a neutrophil count ≥ 1500 cells/mm3; and (iii) appropriately monitored normal thyroid function (TSH and T4) at screening Exclusion Criteria: Immunosuppressive treatment for MN in the 6 months before screening Secondary MN (associated with cancer, infectious disease, autoimmune or iatrogenic disease) Active nephrotic syndrome defined according to KDIGO guidelines by proteinuria > 3.5 g/day (or 3.5 g/g urine sample) and albuminemia < 30 g/L Absence of previous immunological (anti-PLA2R1 antibodies < 14 RU/mL in ELISA or negative indirect immunofluorescence) and clinical (partial or complete) remission Patients with a history of thrombosis or treated with anticoagulants Pregnancy or breastfeeding Cancer in treatment Pre-existing retinopathy Active and severe infections Severe liver failure or cirrhosis Pre-existing severe heart failure Pre-existing psychiatric disorder or patient at risk of anxiety or depression (HAD Score > 11) Patients who use or abuse substances Hypersensitivity to active substance or excipients of study treatment
Sites / Locations
- CHU de NICE
Arms of the Study
Arm 1
Experimental
6-month interferon alfa treatment