Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisPhase 3MASTER-ANCANCT03323476
Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease
A Phase 3 study testing Discontinuation (or not initiation) of Immunosuppressive Therapy and Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl® in people with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis and End Stage Renal Disease, run by Centre Hospitalier Departemental Vendee at 57 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, End Stage Renal Disease
- What is being tested?
- Discontinuation (or not initiation) of Immunosuppressive Therapy and Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 57 sitesFrance
- Study dates
- 2 Feb 2018to Mar 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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.
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
France57 sites
Centre Hospitalier Universitaire Amiens
Amiens
CHU Angers
Angers
Centre Hospitalier Angoulême
Angoulême
Centre Hospitalier ARRAS
Arras
Centre Hospitalier Avignon
Avignon
AUB Santé
Avranches
CHRU Besançon
Besançon
Centre Hospitalier Universitaire Bordeaux
Bordeaux
APHP Ambroise Paré
Boulogne-Billancourt
Centre Hospitalier Boulogne sur Mer
Boulogne-sur-Mer
Centre Hospitalier Universitaire de Brest
Brest
Centre Hospitalier René Dubois - Pontoise
Cergy-Pontoise
Centre Hospitalier Chartres
Chartres
Centre Hospitalier Universitaire G. Montpied
Clermont-Ferrand
Hopital Louis Pasteur
Colmar
Centre Hospitalier Universitaire de Dijon
Dijon
CHI Eure Seine
Évreux
Centre Hospitalier Universitaire Grenoble
Grenoble
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85925
Centre Hospitalier La Rochelle
La Rochelle
Centre ECHO - Le Mans
Le Mans
Centre Hospitalier Le Mans
Le Mans
Centre Hospitalier Emile ROUX
Le Puy-en-Velay
Hôpital Privé La Louvière
Lille, 59042
CHRU Lille
Lille
Centre Hospitalier Universitaire Dupuytren
Limoges
AUB Santé - Lorient
Lorient
Centre Hospitalier Lyon Sud
Lyon
Hopital de la Conception - APHM
Marseille
Centre Hospitalier de Mont de Marsan
Mont-de-Marsan
Centre Hospitalier Universitaire Lapeyronie
Montpellier
GHR Mulhouse Sud Alsace
Mulhouse
Centre Hospitalier Universitaire de Nantes
Nantes
Centre Hospitalier Universitaire Nice
Nice
CHU de Nimes
Nîmes
Aphp - Bichat
Paris
Aphp - Hegp
Paris
APHP - Henri Mondor
Paris
CHU Kremlin - Bicêtre
Paris
Hôpital Saint Louis
Paris
Hôpital Tenon
Paris
Centre Hospitalier Universitaire Poitiers
Poitiers
Centre Hospitalier Quimper
Quimper
AUB Santé - Rennes
Rennes
Centre Hospitalier Universitaire Rennes
Rennes
Centre Hospitalier Universitaire Rouen
Rouen
Centre Hospitalier Saint Brieuc
Saint-Brieuc
Centre Hospitalier Universitaire Saint Etienne
Saint-Etienne
Centre Hospitalier Saint-Nazaire
Saint-Nazaire
Centre Hospitalier Alpes Léman
Sallanches
Centre Hospitalier Saint-Malo
St-Malo
Centre Hospitalier Universitaire Strasbourg
Strasbourg
CHU Toulouse
Toulouse
Clinique Saint Exupéry
Toulouse
CHRU Bretonneau
Tours
Centre Hospitalier Valenciennes
Valenciennes
Centre Hospitalier Bretagne Atlantique
Vannes
About this study
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
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:
Read more
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.
- Being tested
- Discontinuation (or not initiation) of Immunosuppressive Therapy, Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation (or not initiation) of Immunosuppressive TherapyOther
Discontinuation (or not initiation) of Immunosuppressive Therapy
Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®Drug
Maintenance (or initiation) of Immunosuppressive Therapy: Imurel®, Mabthera®,Cellcept®, Cortancyl®
| Study group | Role | What they receive |
|---|---|---|
| Discontinuation of maintenance treatment | Experimental | Not described Receives: Other: Discontinuation (or not initiation) of Immunosuppressive Therapy |
| Maintenance of immunosuppressive treatment | Active comparator | Not described Receives: Drug: Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start2 Feb 2018
- Primary completionMar 2028 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégoire COUVRAT-DESVERGNES, Principal investigator, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323476
- Sponsor's protocol ID
- CHD005-17
- Acronym
- MASTER-ANCA
- Status last verified
- Mar 2026
- First submitted
- 13 Oct 2017
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03323476
- Acronym / sponsor ID
- MASTER-ANCA / CHD005-17
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discontinuation of maintenance treatment | Experimental | Other: Discontinuation (or not initiation) of Immunosuppressive Therapy |
| Maintenance of immunosuppressive treatment | Active comparator | Drug: Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl® |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation (or not initiation) of Immunosuppressive TherapyDiscontinuation (or not initiation) of Immunosuppressive Therapy | Other | Discontinuation of maintenance treatment |
| Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®Maintenance (or initiation) of Immunosuppressive Therapy: Imurel®, Mabthera®,Cellcept®, Cortancyl® | Drug | Maintenance of immunosuppressive treatment |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grégoire COUVRAT-DESVERGNES principal investigator
CHD Vendée
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Discontinuation (or not initiation) of Immunosuppressive Therapy and Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl® in people with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis and End Stage Renal Disease, run by Centre Hospitalier Departemental Vendee at 57 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.