Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease
Status:
Recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
Summary
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.