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Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease
Sponsor: Centre Hospitalier Departemental Vendee
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.
Official title: Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease: a Prospective, Multicenter, Randomized, Open-label, Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2018-02-02
Completion Date
2031-03
Last Updated
2026-03-20
Healthy Volunteers
No
Interventions
Discontinuation (or not initiation) of Immunosuppressive Therapy
Discontinuation (or not initiation) of Immunosuppressive Therapy
Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®
Maintenance (or initiation) of Immunosuppressive Therapy: Imurel®, Mabthera®,Cellcept®, Cortancyl®
Locations (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, 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, 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