Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease
MASTER-ANCA
1 other identifier
interventional
136
1 country
57
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2018
Longer than P75 for phase_3
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 27, 2017
CompletedStudy Start
First participant enrolled
February 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2031
March 20, 2026
March 1, 2026
10.1 years
October 13, 2017
March 18, 2026
Conditions
Outcome Measures
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
During the 24 months of follow-up
Study Arms (2)
Discontinuation of maintenance treatment
EXPERIMENTALMaintenance of immunosuppressive treatment
ACTIVE COMPARATORInterventions
Discontinuation (or not initiation) of Immunosuppressive Therapy
Maintenance (or initiation) of Immunosuppressive Therapy: Imurel®, Mabthera®,Cellcept®, Cortancyl®
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grégoire COUVRAT-DESVERGNES
CHD Vendée
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2017
First Posted
October 27, 2017
Study Start
February 2, 2018
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2031
Last Updated
March 20, 2026
Record last verified: 2026-03