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

Condition(s) studied

Investigational drug(s) / intervention(s)

Discontinuation (or not initiation) of Immunosuppressive Therapy: Discontinuation (or not initiation) of Immunosuppressive Therapy

Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®: Maintenance (or initiation) of Immunosuppressive Therapy: Imurel®, Mabthera®,Cellcept®, Cortancyl®

Study 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.

Eligibility

Primary outcome measure(s)

• 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. — During the 24 months of follow-up
  Severe prejudicial event is defined by the occurrence of: severe infection, major AAV relapse, death

Trial sites (57)

+ 17 more sites — see the full list on the official registry below.

More Centre Hospitalier Departemental Vendee trials in France

Other trials for the same condition