A Phase 3 interventional study of Discontinuation (or not initiation) of Immunosuppressive Therapy and Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl® in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis and End Stage Renal Disease, sponsored by Centre Hospitalier Departemental Vendee. Active, not recruiting at 57 sites in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Centre Hospitalier Departemental Vendee · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Other: Discontinuation (or not initiation) of Immunosuppressive Therapy
Drug: Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®
Discontinuation (or not initiation) of Immunosuppressive Therapy
Maintenance (or initiation) of Immunosuppressive Therapy: Imurel®, Mabthera®,Cellcept®, Cortancyl®
The primary end point will be the time between inclusion and the first severe prejudicial event (measured in days) during 24 months of follow-up.
Severe prejudicial event is defined by the occurrence of: severe infection, major AAV relapse, death
Time frame: During the 24 months of follow-up
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis→
Centre Hospitalier Departemental Vendee