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Active, not recruitingNCT03323476MASTER-ANCAUpdated Mar 20, 2026

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

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

Phase
Phase 3
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

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.

02

Conditions studied

  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
  • End Stage Renal Disease
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (estimated)

Study arms

  • Experimental
    Discontinuation of maintenance treatment

    Other: Discontinuation (or not initiation) of Immunosuppressive Therapy

  • Active comparator
    Maintenance of immunosuppressive treatment

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

Interventions

  • OtherDiscontinuation (or not initiation) of Immunosuppressive Therapy

    Discontinuation (or not initiation) of Immunosuppressive Therapy

  • DrugMaintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®

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

05

What researchers measure

Primary outcomes

  1. 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

06

Study locations

57 sites
  • Centre Hospitalier Universitaire Amiens
    Amiens, France
  • CHU Angers
    Angers, France
  • Centre Hospitalier Angoulême
    Angoulême, France
  • Centre Hospitalier ARRAS
    Arras, France
  • Centre Hospitalier Avignon
    Avignon, France
  • AUB Santé
    Avranches, France
  • CHRU Besançon
    Besançon, France
  • Centre Hospitalier Universitaire Bordeaux
    Bordeaux, France
  • APHP Ambroise Paré
    Boulogne-Billancourt, France
  • Centre Hospitalier Boulogne sur Mer
    Boulogne-sur-Mer, France
  • Centre Hospitalier Universitaire de Brest
    Brest, France
  • Centre Hospitalier René Dubois - Pontoise
    Cergy-Pontoise, France
  • Centre Hospitalier Chartres
    Chartres, France
  • Centre Hospitalier Universitaire G. Montpied
    Clermont-Ferrand, France
  • Hopital Louis Pasteur
    Colmar, France
  • Centre Hospitalier Universitaire de Dijon
    Dijon, France
  • CHI Eure Seine
    Évreux, France
  • Centre Hospitalier Universitaire Grenoble
    Grenoble, France
  • Centre Hospitalier Départemental Vendée
    La Roche-sur-Yon, 85925, France
  • Centre Hospitalier La Rochelle
    La Rochelle, France
  • Centre ECHO - Le Mans
    Le Mans, France
  • Centre Hospitalier Le Mans
    Le Mans, France
  • Centre Hospitalier Emile ROUX
    Le Puy-en-Velay, France
  • Hôpital Privé La Louvière
    Lille, 59042, France
  • CHRU Lille
    Lille, France
  • Centre Hospitalier Universitaire Dupuytren
    Limoges, France
  • AUB Santé - Lorient
    Lorient, France
  • Centre Hospitalier Lyon Sud
    Lyon, France
  • Hopital de la Conception - APHM
    Marseille, France
  • Centre Hospitalier de Mont de Marsan
    Mont-de-Marsan, France
  • Centre Hospitalier Universitaire Lapeyronie
    Montpellier, France
  • GHR Mulhouse Sud Alsace
    Mulhouse, France
  • Centre Hospitalier Universitaire de Nantes
    Nantes, France
  • Centre Hospitalier Universitaire Nice
    Nice, France
  • CHU de Nimes
    Nîmes, France
  • Aphp - Bichat
    Paris, France
  • Aphp - Hegp
    Paris, France
  • APHP - Henri Mondor
    Paris, France
  • CHU Kremlin - Bicêtre
    Paris, France
  • Hôpital Saint Louis
    Paris, France
  • Hôpital Tenon
    Paris, France
  • Centre Hospitalier Universitaire Poitiers
    Poitiers, France
  • Centre Hospitalier Quimper
    Quimper, France
  • AUB Santé - Rennes
    Rennes, France
  • Centre Hospitalier Universitaire Rennes
    Rennes, France
  • Centre Hospitalier Universitaire Rouen
    Rouen, France
  • Centre Hospitalier Saint Brieuc
    Saint-Brieuc, France
  • Centre Hospitalier Universitaire Saint Etienne
    Saint-Etienne, France
  • Centre Hospitalier Saint-Nazaire
    Saint-Nazaire, France
  • Centre Hospitalier Alpes Léman
    Sallanches, France
  • Centre Hospitalier Saint-Malo
    St-Malo, France
  • Centre Hospitalier Universitaire Strasbourg
    Strasbourg, France
  • CHU Toulouse
    Toulouse, France
  • Clinique Saint Exupéry
    Toulouse, France
  • CHRU Bretonneau
    Tours, France
  • Centre Hospitalier Valenciennes
    Valenciennes, France
  • Centre Hospitalier Bretagne Atlantique
    Vannes, France
07

Registry details

Key details

Study ID
NCT03323476
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Oct 27, 2017
Start date
Feb 2, 2018
Primary completion
Mar 2028 (estimated)
Completion
Mar 2031 (estimated)
Last update
Mar 20, 2026

Study contacts

Grégoire COUVRAT-DESVERGNES
principal investigator · CHD Vendée

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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