Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease

This prospective randomized trial aims to evaluate the feasibility, risk and benefit of the discontinuation of immunosuppressive maintenance treatments in AAV (Antineutrophil Cytoplasmic Autoantibodies (ANCA)-associated vasculitis) patients who have reached ESRD (end-stage renal disease). Our hypothesis is that discontinuation of immunosuppressive therapy in AAV patients with ESRD will not expose these patients to an excessive risk of extra-renal AAV relapse, while reducing the rate of complications due to immunosuppression, particularly infections. Patients with ESRD related to AAV will be randomized into 2 arms: arm 1: discontinuation (or not initiation) of maintenance treatment (Experimental group) arm 2: maintenance (or initiation) of immunosuppressive treatment (Control group). The main objective of this study is to demonstrate a superiority of immunosuppression discontinuation in ESRD-AAV patients compared to standard maintenance immunosuppressive therapy in terms of severe prejudicial event-free survival at 24 months. The second objectives include the frequency of major and minor relapses, of infectious episodes and leukopenia in both groups and the establishment of a prospective database regarding the outcome of ESRD-AAV patients.

NCT Number	NCT03323476
Lead Sponsor	Centre Hospitalier Departemental Vendee
Conditions	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, End Stage Renal Disease
Enrollment	136 participants
Start Date	2018-02-02
Primary Completion	2028-03 (estimated)
Study Completion	2031-03 (estimated)
Updated on ClinicalTrials.gov	2026-03-20