Study of immunological activity after personalized immunomodulatory therapy regulating the Th17 pathway in patients with extramembranous glomerulonephritis - 22-AOIP-03

Centre Hospitalier Universitaire De Nice0 个研究点目标入组 5 人开始时间: 2023年3月6日最近更新: 2024年8月21日

适应症

试验速览

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•Subjects 18 years or older, GEM with anti-PLA2R1 autoantibody, Immunological relapse (defined by an increase in anti-PLA2R1 antibody titre > 14 RU/mL after a negative phase of anti-PLA2R1 antibodies, that is, immunological remission), IL-17A plasma levels > 73 pg/mL after non-specific stimulation of peripheral blood immune cells, Symptomatic antiprotein treatment with stable and maximum tolerated dosage, Patients with a biological workup at the screening visit 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)

•Immunosuppressive treatment for GEM within 6 months prior to the screening visit, Cancer under treatment, Pre-existing retinopathies, Active and severe infections, Severe liver failure or cirrhosis, Pregnancy or breastfeeding, Pre-existing severe heart failure, Pre-existing psychiatric disorder or patient likely to be anxious or depressed (HAD score > 11), Patients using substances or abusing substances, Hypersensitivity to the active substance or excipients of the study treatment, Secondary GEM (associated with cancer, infectious disease, autoimmune or iatrogenic disease), Active nephrotic syndrome defined by KDIGO guidelines as proteinuria > 3.5 g/day (or 3.5 g/g on urine sample) and albumin < 30 g/L, Absence of immunological (anti-PLA2R1 antibody < 14 RU/mL in ELISA or negative indirect immunofluorescence) and clinical (partial or complete) remission, Patients with a history of thrombosis or on anticoagulant therapy

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