Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease

Phase 3

Recruiting

• Conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; End Stage Renal Disease
• Interventions: Other: Discontinuation (or not initiation) of Immunosuppressive Therapy

• Registration Number: NCT03323476
• Lead Sponsor: Centre Hospitalier Departemental Vendee

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-27
• Study Start: 2018-02-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2031-03
• Study Completion: 2031-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discontinuation of maintenance treatment	Discontinuation (or not initiation) of Immunosuppressive Therapy	-

Primary Outcome Measures

Name	Time	Method
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.	During the 24 months of follow-up	Severe prejudicial event is defined by the occurrence of: severe infection, major AAV relapse, death

Trial Locations

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

Centre Hospitalier Boulogne sur Mer; 🇫🇷 Boulogne-sur-Mer, France

Centre Hospitalier Jacques Coeur; 🇫🇷 Bourges, 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

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; 🇫🇷 Nimes, 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-Nazaire; 🇫🇷 Saint Nazaire, France

Centre Hospitalier Saint Brieuc; 🇫🇷 Saint-Brieuc, France

Centre Hospitalier Saint-Malo; 🇫🇷 Saint-Malo, France

Centre Hospitalier Universitaire Saint Etienne; 🇫🇷 Saint-Étienne, France

Centre Hospitalier Alpes Léman; 🇫🇷 Sallanches, 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

CHI Eure Seine; 🇫🇷 Évreux, France