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

March 18, 2026 updated by: Centre Hospitalier Departemental Vendee

Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease: a Prospective, Multicenter, Randomized, Open-label, Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France
        • Centre Hospitalier Universitaire Amiens
      • Angers, France
        • CHU Angers
      • Angoulême, France
        • Centre Hospitalier Angoulême
      • Arras, France
        • Centre Hospitalier ARRAS
      • Avignon, France
        • Centre Hospitalier Avignon
      • Avranches, France
        • AUB Santé
      • Besançon, France
        • CHRU Besançon
      • Bordeaux, France
        • Centre Hospitalier Universitaire Bordeaux
      • Boulogne-Billancourt, France
        • APHP Ambroise Paré
      • Boulogne-sur-Mer, France
        • Centre Hospitalier Boulogne sur Mer
      • Brest, France
        • Centre Hospitalier Universitaire de Brest
      • Cergy-Pontoise, France
        • Centre Hospitalier René Dubois - Pontoise
      • Chartres, France
        • Centre Hospitalier Chartres
      • Clermont-Ferrand, France
        • Centre Hospitalier Universitaire G. Montpied
      • Colmar, France
        • Hopital Louis Pasteur
      • Dijon, France
        • Centre Hospitalier Universitaire De Dijon
      • Grenoble, France
        • Centre Hospitalier Universitaire Grenoble
      • La Roche-sur-Yon, France, 85925
        • Centre Hospitalier Departemental Vendee
      • La Rochelle, France
        • Centre Hospitalier La Rochelle
      • Le Mans, France
        • Centre Hospitalier Le Mans
      • Le Mans, France
        • Centre ECHO - Le Mans
      • Le Puy-en-Velay, France
        • Centre Hospitalier Emile Roux
      • Lille, France
        • CHRU Lille
      • Lille, France, 59042
        • Hôpital privé La Louvière
      • Limoges, France
        • Centre Hospitalier Universitaire Dupuytren
      • Lorient, France
        • AUB Santé - Lorient
      • Lyon, France
        • Centre Hospitalier Lyon Sud
      • Marseille, France
        • Hopital de la Conception - APHM
      • Mont-de-Marsan, France
        • Centre Hospitalier de Mont de Marsan
      • Montpellier, France
        • Centre Hospitalier Universitaire Lapeyronie
      • Mulhouse, France
        • GHR Mulhouse Sud Alsace
      • Nantes, France
        • Centre Hospitalier Universitaire De Nantes
      • Nice, France
        • Centre Hospitalier Universitaire Nice
      • Nîmes, France
        • CHU de Nîmes
      • Paris, France
        • Hopital Saint Louis
      • Paris, France
        • Aphp - Bichat
      • Paris, France
        • Hopital Tenon
      • Paris, France
        • Aphp - Hegp
      • Paris, France
        • APHP - Henri Mondor
      • Paris, France
        • CHU Kremlin - Bicêtre
      • Poitiers, France
        • Centre Hospitalier Universitaire Poitiers
      • Quimper, France
        • Centre Hospitalier Quimper
      • Rennes, France
        • Centre Hospitalier Universitaire Rennes
      • Rennes, France
        • AUB Santé - Rennes
      • Rouen, France
        • Centre Hospitalier Universitaire Rouen
      • Saint-Brieuc, France
        • Centre Hospitalier Saint Brieuc
      • Saint-Etienne, France
        • Centre Hospitalier Universitaire Saint Etienne
      • Saint-Nazaire, France
        • Centre Hospitalier Saint-Nazaire
      • Sallanches, France
        • Centre Hospitalier Alpes Leman
      • St-Malo, France
        • Centre Hospitalier Saint-Malo
      • Strasbourg, France
        • Centre Hospitalier Universitaire Strasbourg
      • Toulouse, France
        • CHU Toulouse
      • Toulouse, France
        • Clinique Saint Exupéry
      • Tours, France
        • CHRU Bretonneau
      • Valenciennes, France
        • Centre Hospitalier Valenciennes
      • Vannes, France
        • Centre Hospitalier Bretagne Atlantique
      • Évreux, France
        • CHI Eure Seine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Discontinuation of maintenance treatment
Other: Discontinuation (or not initiation) of Immunosuppressive Therapy
Discontinuation (or not initiation) of Immunosuppressive Therapy
Active Comparator: Maintenance of immunosuppressive treatment
Drug: Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®
Maintenance (or initiation) of Immunosuppressive Therapy: Imurel®, Mabthera®,Cellcept®, Cortancyl®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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.
Time Frame: During the 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Departemental Vendee

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Grégoire COUVRAT-DESVERGNES, CHD Vendee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHD005-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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