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

End Stage Renal Disease Clinical Trial

— MASTER-ANCA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03323476
• Other study ID #: CHD005-17
• Status: Recruiting
• Phase: Phase 3
• Start date: February 2, 2018
• Est. completion date: March 2031

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Departemental Vendee
• Contact: Chloé MOREAU
• Phone: 0251446572
• Email: chloe.moreau[@]chd-vendee.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: March 2031
• Est. primary completion date: March 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Vasculitis

Intervention

Other:
• Discontinuation (or not initiation) of Immunosuppressive Therapy
Discontinuation (or not initiation) of Immunosuppressive Therapy

Drug:
• Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®
Maintenance (or initiation) of Immunosuppressive Therapy: Imurel®, Mabthera®,Cellcept®, Cortancyl®

Locations

Country	Name	City	State
France	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	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	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	CHRU Lille	Lille
France	Hôpital Privé La Louvière	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 Universitaire Saint Etienne	Saint-Étienne
France	Centre Hospitalier Saint-Malo	Saint-Malo
France	Centre Hospitalier Alpes Léman	Sallanches
France	Centre Hospitalier Universitaire Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse
France	CHRU Bretonneau	Tours
France	Centre Hospitalier Valenciennes	Valenciennes
France	Centre Hospitalier Bretagne Atlantique	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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