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
Interventional
Phase 3
Centre Hospitalier Departemental Vendee (Voir sur ClinicalTrials)
février 2018
mars 2031
02 décembre 2025
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) | ||||
| GPE HOSP BROUSSAIS HEGP | Contact (sur clinicalTrials) | ||||
| HOPITAL NOVO | 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 2997577 - France | Contact (sur clinicalTrials) | ||||
| AUB Santé - Rennes - Rennes 2983990 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Alpes Léman - Sallanches 2976406 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Départemental Vendée - 85925 - La Roche-sur-Yon 3006767 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Emile ROUX - Le Puy-en-Velay 3002465 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Lyon Sud - Lyon 2996944 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Saint Brieuc - Saint-Brieuc 2981280 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Saint-Malo - St-Malo 2978640 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire G. Montpied - Clermont-Ferrand 3024635 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Grenoble - Grenoble 3014728 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Nice - Nice 2990440 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Poitiers - Poitiers 2986495 - France | Contact (sur clinicalTrials) | ||||
| CHRU Besançon - Besançon 3033123 - France | Contact (sur clinicalTrials) | ||||
| CHU Toulouse - Toulouse 2972315 - France | Contact (sur clinicalTrials) | ||||
| GHR Mulhouse Sud Alsace - Mulhouse 2991214 - France | Contact (sur clinicalTrials) | ||||
| Hopital de la Conception - APHM - Marseille 2995469 - France | Contact (sur clinicalTrials) | ||||
| Hopital Louis Pasteur - Colmar 3024297 - 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 Ambroise Paré - Boulogne-Billancourt 3031137 - France | Contact (sur clinicalTrials) | ||||
| AUB Santé - Avranches 3035639 - France | Contact (sur clinicalTrials) | ||||
| Centre ECHO - Le Mans - Le Mans 3003603 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Angoulême - Angoulême 3037598 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier ARRAS - Arras 3036784 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Avignon - Avignon 3035681 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Boulogne sur Mer - Boulogne-sur-Mer 3031133 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Bretagne Atlantique - Vannes 2970777 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Chartres - Chartres 3026467 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Mont de Marsan - Mont-de-Marsan 2992771 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Jacques Coeur - Bourges 3031005 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier La Rochelle - La Rochelle 3006787 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Le Mans - Le Mans 3003603 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Quimper - Quimper 2984701 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Saint-Nazaire - Saint-Nazaire 2977921 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Amiens - Amiens 3037854 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Bordeaux - Bordeaux 3031582 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Brest - Brest 3030300 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Dijon - Dijon 3021372 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nantes - Nantes 2990969 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Dupuytren - Limoges 2998286 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Lapeyronie - Montpellier 2992166 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Rennes - Rennes 2983990 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Rouen - Rouen 2982652 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Saint Etienne - Saint-Etienne 2980291 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Strasbourg - Strasbourg 2973783 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Valenciennes - Valenciennes 2971041 - France | Contact (sur clinicalTrials) | ||||
| CHI Eure Seine - Évreux 3019265 - France | Contact (sur clinicalTrials) | ||||
| CHRU Bretonneau - Tours 2972191 - France | Contact (sur clinicalTrials) | ||||
| CHRU Lille - Lille 2998324 - France | Contact (sur clinicalTrials) | ||||
| CHU Angers - Angers 3037656 - France | Contact (sur clinicalTrials) | ||||
| CHU de Nimes - Nîmes 2990363 - France | Contact (sur clinicalTrials) | ||||
| Clinique Saint Exupéry - Toulouse 2972315 - France | Contact (sur clinicalTrials) | ||||
| Hôpital Privé La Louvière - 59042 - Lille 2998324 - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint Louis - Paris 2988507 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- 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.