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

Primary Purpose

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, End Stage Renal Disease

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Discontinuation (or not initiation) of Immunosuppressive Therapy
Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Universitaire AmiensRecruiting
  • CHU AngersRecruiting
  • Centre Hospitalier Angoulême
  • Centre Hospitalier ARRASRecruiting
  • Centre Hospitalier AvignonRecruiting
  • CHRU Besançon
  • Centre Hospitalier Universitaire Bordeaux
  • Centre Hospitalier Boulogne sur MerRecruiting
  • Centre Hospitalier Jacques Coeur
  • Centre Hospitalier Universitaire de BrestRecruiting
  • Centre Hospitalier René Dubois - Pontoise
  • Centre Hospitalier ChartresRecruiting
  • Centre Hospitalier Universitaire G. MontpiedRecruiting
  • Hopital Louis PasteurRecruiting
  • Centre Hospitalier Universitaire de Dijon
  • Centre Hospitalier Universitaire GrenobleRecruiting
  • Centre Hospitalier Départemental VendéeRecruiting
  • Centre Hospitalier La RochelleRecruiting
  • Centre ECHO - Le MansRecruiting
  • Centre Hospitalier Le MansRecruiting
  • Centre Hospitalier Emile ROUX
  • Hôpital Privé La LouvièreRecruiting
  • CHRU LilleRecruiting
  • Centre Hospitalier Universitaire Dupuytren
  • AUB Santé - LorientRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Hopital de la Conception - APHMRecruiting
  • Centre Hospitalier de Mont de MarsanRecruiting
  • Centre Hospitalier Universitaire LapeyronieRecruiting
  • GHR Mulhouse Sud AlsaceRecruiting
  • Centre Hospitalier Universitaire de NantesRecruiting
  • Centre Hospitalier Universitaire NiceRecruiting
  • CHU de NimesRecruiting
  • Aphp - BichatRecruiting
  • Aphp - HegpRecruiting
  • APHP - Henri MondorRecruiting
  • CHU Kremlin - Bicêtre
  • Hôpital Saint LouisRecruiting
  • Hôpital TenonRecruiting
  • Centre Hospitalier Universitaire PoitiersRecruiting
  • Centre Hospitalier QuimperRecruiting
  • AUB Santé - RennesRecruiting
  • Centre Hospitalier Universitaire RennesRecruiting
  • Centre Hospitalier Universitaire RouenRecruiting
  • Centre Hospitalier Saint-NazaireRecruiting
  • Centre Hospitalier Saint BrieucRecruiting
  • Centre Hospitalier Saint-MaloRecruiting
  • Centre Hospitalier Universitaire Saint EtienneRecruiting
  • Centre Hospitalier Alpes LémanRecruiting
  • Centre Hospitalier Universitaire StrasbourgRecruiting
  • CHU ToulouseRecruiting
  • CHRU BretonneauRecruiting
  • Centre Hospitalier ValenciennesRecruiting
  • Centre Hospitalier Bretagne AtlantiqueRecruiting
  • CHI Eure SeineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Discontinuation of maintenance treatment

Maintenance of immunosuppressive treatment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 13, 2017
Last Updated
May 12, 2023
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT03323476
Brief Title
Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
March 2031 (Anticipated)
Study Completion Date
March 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Discontinuation of maintenance treatment
Arm Type
Experimental
Arm Title
Maintenance of immunosuppressive treatment
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Discontinuation (or not initiation) of Immunosuppressive Therapy
Intervention Description
Discontinuation (or not initiation) of Immunosuppressive Therapy
Intervention Type
Drug
Intervention Name(s)
Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®
Intervention Description
Maintenance (or initiation) of Immunosuppressive Therapy: Imurel®, Mabthera®,Cellcept®, Cortancyl®
Primary Outcome Measure Information:
Title
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.
Description
Severe prejudicial event is defined by the occurrence of: severe infection, major AAV relapse, death
Time Frame
During the 24 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chloé MOREAU
Phone
0251446572
Email
chloe.moreau@chd-vendee.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grégoire COUVRAT-DESVERGNES
Organizational Affiliation
CHD Vendée
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Amiens
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitri TITECA-BEAUPORT
Facility Name
CHU Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit BRILLAND
Facility Name
Centre Hospitalier Angoulême
City
Angoulême
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique BLANCHIER
Facility Name
Centre Hospitalier ARRAS
City
Arras
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abo Bakr ABD EL FATAH MOHAMED
Facility Name
Centre Hospitalier Avignon
City
Avignon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David VERHELST
Facility Name
CHRU Besançon
City
Besançon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier DUCLOUX
Facility Name
Centre Hospitalier Universitaire Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian COMBE
Facility Name
Centre Hospitalier Boulogne sur Mer
City
Boulogne-sur-Mer
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafik MESBAH
Facility Name
Centre Hospitalier Jacques Coeur
City
Bourges
Country
France
Individual Site Status
Withdrawn
Facility Name
Centre Hospitalier Universitaire de Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine HANROTEL-SALIOU
Facility Name
Centre Hospitalier René Dubois - Pontoise
City
Cergy-Pontoise
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte JOUZEL
Facility Name
Centre Hospitalier Chartres
City
Chartres
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine ALBERT
Facility Name
Centre Hospitalier Universitaire G. Montpied
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien ANIORT
Facility Name
Hopital Louis Pasteur
City
Colmar
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre KLEIN
Facility Name
Centre Hospitalier Universitaire de Dijon
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu LEGENDRE
Facility Name
Centre Hospitalier Universitaire Grenoble
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Louis CARRON
Facility Name
Centre Hospitalier Départemental Vendée
City
La Roche sur yon
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire COUVRAT-DESVERGNES
Facility Name
Centre Hospitalier La Rochelle
City
La Rochelle
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François POURREAU
Facility Name
Centre ECHO - Le Mans
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guilaume SERET
Facility Name
Centre Hospitalier Le Mans
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe COINDRE
Facility Name
Centre Hospitalier Emile ROUX
City
Le Puy-en-Velay
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Privé La Louvière
City
Lille
ZIP/Postal Code
59042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence VRIGNEAUD
Facility Name
CHRU Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline LEBAS
Facility Name
Centre Hospitalier Universitaire Dupuytren
City
Limoges
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie ESSIG
Facility Name
AUB Santé - Lorient
City
Lorient
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabrielle DUNEAU
Facility Name
Centre Hospitalier Lyon Sud
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leatitia KOPPE
Facility Name
Hopital de la Conception - APHM
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noémie JOURDE
Facility Name
Centre Hospitalier de Mont de Marsan
City
Mont-de-Marsan
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magali JASIEK
Facility Name
Centre Hospitalier Universitaire Lapeyronie
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume JEANTET
Facility Name
GHR Mulhouse Sud Alsace
City
Mulhouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François CHANTREL
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clément DELTOMBE
Facility Name
Centre Hospitalier Universitaire Nice
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine ANDREANI
Facility Name
CHU de Nimes
City
Nimes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier MORANNE
Facility Name
Aphp - Bichat
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric DAUGAS
Facility Name
Aphp - Hegp
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges-Alexandre KARRAS
Facility Name
APHP - Henri Mondor
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nizar JOHER
Facility Name
CHU Kremlin - Bicêtre
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine DURRBACH
Facility Name
Hôpital Saint Louis
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evangéline PILLEBOUT
Facility Name
Hôpital Tenon
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques BOFFA
Facility Name
Centre Hospitalier Universitaire Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank BRIDOUX
Facility Name
Centre Hospitalier Quimper
City
Quimper
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale SIOHAN
Facility Name
AUB Santé - Rennes
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric LARUELLE
Facility Name
Centre Hospitalier Universitaire Rennes
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elsa VABRET
Facility Name
Centre Hospitalier Universitaire Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique GUERROT
Facility Name
Centre Hospitalier Saint-Nazaire
City
Saint Nazaire
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique BESNIER
Facility Name
Centre Hospitalier Saint Brieuc
City
Saint-Brieuc
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline FREGUIN
Facility Name
Centre Hospitalier Saint-Malo
City
Saint-Malo
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric RENAUDINEAU
Facility Name
Centre Hospitalier Universitaire Saint Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe MARIAT
Facility Name
Centre Hospitalier Alpes Léman
City
Sallanches
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin JANNOT
Facility Name
Centre Hospitalier Universitaire Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno MOULIN
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique CHAUVEAU
Facility Name
CHRU Bretonneau
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Michel HALIMI
Facility Name
Centre Hospitalier Valenciennes
City
Valenciennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire CARTERY
Facility Name
Centre Hospitalier Bretagne Atlantique
City
Vannes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugoline BOULAY
Facility Name
CHI Eure Seine
City
Évreux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ancuta BOUFFANDEAU

12. IPD Sharing Statement

Learn more about this trial

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

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