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

March 18, 2026 updated by: Centre Hospitalier Departemental Vendee

Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease: a Prospective, Multicenter, Randomized, Open-label, Clinical Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Centre Hospitalier Universitaire Amiens
      • Angers, France
        • CHU Angers
      • Angoulême, France
        • Centre Hospitalier Angoulême
      • Arras, France
        • Centre Hospitalier ARRAS
      • Avignon, France
        • Centre Hospitalier Avignon
      • Avranches, France
        • AUB Santé
      • Besançon, France
        • CHRU Besançon
      • Bordeaux, France
        • Centre Hospitalier Universitaire Bordeaux
      • Boulogne-Billancourt, France
        • APHP Ambroise Paré
      • Boulogne-sur-Mer, France
        • Centre Hospitalier Boulogne sur Mer
      • Brest, France
        • Centre Hospitalier Universitaire de Brest
      • Cergy-Pontoise, France
        • Centre Hospitalier René Dubois - Pontoise
      • Chartres, France
        • Centre Hospitalier Chartres
      • Clermont-Ferrand, France
        • Centre Hospitalier Universitaire G. Montpied
      • Colmar, France
        • Hopital Louis Pasteur
      • Dijon, France
        • Centre Hospitalier Universitaire De Dijon
      • Grenoble, France
        • Centre Hospitalier Universitaire Grenoble
      • La Roche-sur-Yon, France, 85925
        • Centre Hospitalier Departemental Vendee
      • La Rochelle, France
        • Centre Hospitalier La Rochelle
      • Le Mans, France
        • Centre Hospitalier Le Mans
      • Le Mans, France
        • Centre ECHO - Le Mans
      • Le Puy-en-Velay, France
        • Centre Hospitalier Emile Roux
      • Lille, France
        • CHRU Lille
      • Lille, France, 59042
        • Hôpital privé La Louvière
      • Limoges, France
        • Centre Hospitalier Universitaire Dupuytren
      • Lorient, France
        • AUB Santé - Lorient
      • Lyon, France
        • Centre Hospitalier Lyon Sud
      • Marseille, France
        • Hopital de la Conception - APHM
      • Mont-de-Marsan, France
        • Centre Hospitalier de Mont de Marsan
      • Montpellier, France
        • Centre Hospitalier Universitaire Lapeyronie
      • Mulhouse, France
        • GHR Mulhouse Sud Alsace
      • Nantes, France
        • Centre Hospitalier Universitaire De Nantes
      • Nice, France
        • Centre Hospitalier Universitaire Nice
      • Nîmes, France
        • CHU de Nîmes
      • Paris, France
        • Hopital Saint Louis
      • Paris, France
        • Aphp - Bichat
      • Paris, France
        • Hôpital Tenon
      • Paris, France
        • Aphp - Hegp
      • Paris, France
        • APHP - Henri Mondor
      • Paris, France
        • CHU Kremlin - Bicêtre
      • Poitiers, France
        • Centre Hospitalier Universitaire Poitiers
      • Quimper, France
        • Centre Hospitalier Quimper
      • Rennes, France
        • Centre Hospitalier Universitaire Rennes
      • Rennes, France
        • AUB Santé - Rennes
      • Rouen, France
        • Centre Hospitalier Universitaire Rouen
      • Saint-Brieuc, France
        • Centre Hospitalier Saint Brieuc
      • Saint-Etienne, France
        • Centre Hospitalier Universitaire Saint Etienne
      • Saint-Nazaire, France
        • Centre Hospitalier Saint-Nazaire
      • Sallanches, France
        • Centre Hospitalier Alpes Leman
      • St-Malo, France
        • Centre Hospitalier Saint-Malo
      • Strasbourg, France
        • Centre Hospitalier Universitaire Strasbourg
      • Toulouse, France
        • CHU Toulouse
      • Toulouse, France
        • Clinique Saint Exupéry
      • Tours, France
        • CHRU Bretonneau
      • Valenciennes, France
        • Centre Hospitalier Valenciennes
      • Vannes, France
        • Centre Hospitalier Bretagne Atlantique
      • Évreux, France
        • CHI Eure Seine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years and ≤ 90 years
  • Patients affected by a GPA or MPA AAV with a renal injury
  • Patients with initial manifestation or relapse of AAV
  • Patients with ESRD, defined by a glomerular filtration rate estimated using the MDRD formula ≤15 mL/min or requirement for dialysis for more than 60 days
  • Patients with ESRD on native kidney
  • Patients who gave written informed consent for participation in the study
  • Patients with affiliation to the French social security system

Exclusion Criteria:

  • Patients who experienced severe extra-renal disease due to AAV (intra-alveolar haemorrhage with blood oxygen saturation ≤ 85% on room air or ventilated, or central nervous system disease) in the last 12 months prior to inclusion
  • Patients with AAV-associated renal involvement (with active inflammatory lesions in kidney biopsy) diagnosed less than three months and receiving induction treatment with cyclophosphamide or rituximab or diagnosed less than 45 days for patients who have receveid only treatment based on steroid infusion without cyclophosphamide or rituximab
  • Patients who received maintenance immunosuppressive treatment for more than 6 months during the last 12 months
  • Patient with a diagnosis of vasculitis other than GPA or MPA
  • Patients with another immunologic systemic disease (Lupus, sarcoidosis…) Patients with active HCV, HBV or HIV infection
  • Patients with a history of serious viral infection (CMV, HHV8, etc.) in the 2 months prior to the inclusion, or severe uncontrolled chronic infection (tuberculosis, etc.)
  • Patients with uncontrolled cancer or hemopathy
  • Kidney transplant patient
  • Inability to understand and sign the informed consent
  • Pregnant women.
  • Women of child-bearing age without effective method of contraception
  • Age < 18 years or > 90 years.
  • Patients under guardianship or trusteeship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Discontinuation of maintenance treatment
Other: Discontinuation (or not initiation) of Immunosuppressive Therapy
Discontinuation (or not initiation) of Immunosuppressive Therapy
Active Comparator: Maintenance of immunosuppressive treatment
Drug: Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®
Maintenance (or initiation) of Immunosuppressive Therapy: Imurel®, Mabthera®,Cellcept®, Cortancyl®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: During the 24 months of follow-up
Severe prejudicial event is defined by the occurrence of: severe infection, major AAV relapse, death
During the 24 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Principal Investigator: Grégoire COUVRAT-DESVERGNES, CHD Vendee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2018

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

October 26, 2017

First Posted (Actual)

October 27, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD005-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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