Informations générales (source: ClinicalTrials.gov)
Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease: a Prospective, Multicenter, Randomized, Open-label, Clinical Trial (MASTER-ANCA)
Interventional
Phase 3
Centre Hospitalier Departemental Vendee (Voir sur ClinicalTrials)
février 2018
mars 2031
17 juillet 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bicêtre | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Bichat | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| HOPITAL NOVO | Contact (sur clinicalTrials) | ||||
| IFSI DE L'HÔPITAL SAINT LOUIS | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AUB Santé - Lorient - Lorient - France | Contact (sur clinicalTrials) | ||||
| AUB Santé - Rennes - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Alpes Léman - Sallanches - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Angoulême - Angoulême - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier ARRAS - Arras - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Avignon - Avignon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Boulogne sur Mer - Boulogne-sur-Mer - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Bretagne Atlantique - Vannes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Chartres - Chartres - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Mont de Marsan - Mont-de-Marsan - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Départemental Vendée - 85925 - La Roche sur yon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Saint Brieuc - Saint-Brieuc - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Saint-Malo - Saint-Malo - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Saint-Nazaire - Saint Nazaire - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Amiens - Amiens - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Bordeaux - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Brest - Brest - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Dijon - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Lapeyronie - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Rennes - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Rouen - Rouen - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Saint Etienne - Saint-Étienne - France | Contact (sur clinicalTrials) | ||||
| CHI Eure Seine - Évreux - France | Contact (sur clinicalTrials) | ||||
| CHRU Besançon - Besançon - France | Contact (sur clinicalTrials) | ||||
| CHRU Bretonneau - Tours - France | Contact (sur clinicalTrials) | ||||
| Hopital de la Conception - APHM - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hopital Louis Pasteur - Colmar - France | Contact (sur clinicalTrials) | ||||
| Hôpital Privé La Louvière - 59042 - Lille - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Aphp - Hegp - Paris - France | Contact (sur clinicalTrials) | ||||
| Centre ECHO - Le Mans - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Emile ROUX - Le Puy-en-Velay - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Jacques Coeur - Bourges - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier La Rochelle - La Rochelle - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Le Mans - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Lyon Sud - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Quimper - Quimper - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nantes - Nantes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Dupuytren - Limoges - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire G. Montpied - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Grenoble - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Nice - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Poitiers - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Strasbourg - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Valenciennes - Valenciennes - France | Contact (sur clinicalTrials) | ||||
| CHRU Lille - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU Angers - Angers - France | Contact (sur clinicalTrials) | ||||
| CHU de Nimes - Nimes - France | Contact (sur clinicalTrials) | ||||
| CHU Toulouse - Toulouse - France | Contact (sur clinicalTrials) | ||||
| GHR Mulhouse Sud Alsace - Mulhouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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.