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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discontinuation of maintenance treatment | Experimental |
| |
| Maintenance of immunosuppressive treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discontinuation (or not initiation) of Immunosuppressive Therapy | Other | Discontinuation (or not initiation) of Immunosuppressive Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grégoire COUVRAT-DESVERGNES | CHD Vendée | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Amiens | Amiens | France | ||||
| CHU Angers |
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| Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl® | Drug | Maintenance (or initiation) of Immunosuppressive Therapy: Imurel®, Mabthera®,Cellcept®, Cortancyl® |
|
| 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 |
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007165 | Immunosuppression Therapy |
| D008283 | Maintenance |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D005159 | Health Care Facilities Workforce and Services |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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