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
16 novembre 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 | Antoine DURRBACH | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Bichat | Eric DAUGAS | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Nizar JOHER | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Jean-Jacques BOFFA | Contact (sur clinicalTrials) | |||
| HOPITAL NOVO | Charlotte JOUZEL | Contact (sur clinicalTrials) | |||
| IFSI DE L'HÔPITAL SAINT LOUIS | Evangéline PILLEBOUT | 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 | Gabrielle DUNEAU | Contact (sur clinicalTrials) | |||
| AUB Santé - Rennes - Rennes - France | Eric LARUELLE | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Alpes Léman - Sallanches - France | Martin JANNOT | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Angoulême - Angoulême - France | Dominique BLANCHIER | Contact (sur clinicalTrials) | |||
| Centre Hospitalier ARRAS - Arras - France | Abo Bakr ABD EL FATAH MOHAMED | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Avignon - Avignon - France | David VERHELST | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Boulogne sur Mer - Boulogne-sur-Mer - France | Rafik MESBAH | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Bretagne Atlantique - Vannes - France | Hugoline BOULAY | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Chartres - Chartres - France | Catherine ALBERT | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Mont de Marsan - Mont-de-Marsan - France | Magali JASIEK | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Départemental Vendée - 85925 - La Roche sur yon - France | Grégoire COUVRAT-DESVERGNES | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Saint Brieuc - Saint-Brieuc - France | Caroline FREGUIN | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Saint-Malo - Saint-Malo - France | Eric RENAUDINEAU | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Saint-Nazaire - Saint Nazaire - France | Dominique BESNIER | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Amiens - Amiens - France | Dimitri TITECA-BEAUPORT | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Bordeaux - Bordeaux - France | Christian COMBE | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Brest - Brest - France | Catherine HANROTEL-SALIOU | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Dijon - Dijon - France | Mathieu LEGENDRE | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Lapeyronie - Montpellier - France | Guillaume JEANTET | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Rennes - Rennes - France | Elsa VABRET | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Rouen - Rouen - France | Dominique GUERROT | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Saint Etienne - Saint-Étienne - France | Christophe MARIAT | Contact (sur clinicalTrials) | |||
| CHI Eure Seine - Évreux - France | Ancuta BOUFFANDEAU | Contact (sur clinicalTrials) | |||
| CHRU Besançon - Besançon - France | Didier DUCLOUX | Contact (sur clinicalTrials) | |||
| CHRU Bretonneau - Tours - France | Jean Michel HALIMI | Contact (sur clinicalTrials) | |||
| Hopital de la Conception - APHM - Marseille - France | Noémie JOURDE | Contact (sur clinicalTrials) | |||
| Hopital Louis Pasteur - Colmar - France | Alexandre KLEIN | Contact (sur clinicalTrials) | |||
| Hôpital Privé La Louvière - 59042 - Lille - France | Laurence VRIGNEAUD | 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 | Georges-Alexandre KARRAS | Contact (sur clinicalTrials) | |||
| Centre ECHO - Le Mans - Le Mans - France | Guilaume SERET | 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 | François POURREAU | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Le Mans - Le Mans - France | Jean-Philippe COINDRE | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Lyon Sud - Lyon - France | Leatitia KOPPE | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Quimper - Quimper - France | Pascale SIOHAN | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Nantes - Nantes - France | Clément DELTOMBE | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Dupuytren - Limoges - France | Marie ESSIG | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire G. Montpied - Clermont-Ferrand - France | Julien ANIORT | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Grenoble - Grenoble - France | Pierre-Louis CARRON | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Nice - Nice - France | Marine ANDREANI | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Poitiers - Poitiers - France | Frank BRIDOUX | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Strasbourg - Strasbourg - France | Bruno MOULIN | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Valenciennes - Valenciennes - France | Claire CARTERY | Contact (sur clinicalTrials) | |||
| CHRU Lille - Lille - France | Céline LEBAS | Contact (sur clinicalTrials) | |||
| CHU Angers - Angers - France | Jean françois AUGUSTO | Contact (sur clinicalTrials) | |||
| CHU de Nimes - Nimes - France | Olivier MORANNE | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Toulouse - France | Dominique CHAUVEAU | Contact (sur clinicalTrials) | |||
| Clinique Saint Exupéry - Toulouse - France | Antoine DELARCHE | Contact (sur clinicalTrials) | |||
| GHR Mulhouse Sud Alsace - Mulhouse - France | François CHANTREL | 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.