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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03323476
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : February 15, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis End Stage Renal Disease Other: Discontinuation (or not initiation) of Immunosuppressive Therapy Drug: Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl® Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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®

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.
  • 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 positive anti-glomerular basement membrane antibodies.
  • 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.
  • Inability to understand and sign the informed consent.
  • Pregnant women.
  • Age < 18 years or > 90 years.
  • Patients under guardianship or trusteeship.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03323476

Contact: Chloé MOREAU 0251446572

Centre Hospitalier Universitaire Amiens Not yet recruiting
Amiens, France
Principal Investigator: Gabriel CHOUKROUN         
Centre Hospitalier Angoulême Not yet recruiting
Angoulême, France
Principal Investigator: Dominique BLANCHIER         
Centre Hospitalier Avignon Not yet recruiting
Avignon, France
Principal Investigator: David VERHELST         
CHRU Besançon Not yet recruiting
Besançon, France
Principal Investigator: Didier DUCLOUX         
Centre Hospitalier Universitaire Bordeaux Not yet recruiting
Bordeaux, France
Principal Investigator: Christian COMBE         
Centre Hospitalier Universitaire de Brest Recruiting
Brest, France
Principal Investigator: Catherine HANROTEL-SALIOU         
Centre Hospitalier Chartres Not yet recruiting
Chartres, France
Principal Investigator: Catherine ALBERT         
Centre Hospitalier Universitaire G. Montpied Not yet recruiting
Clermont-Ferrand, France
Principal Investigator: Julien ANIORT         
Hopital Louis Pasteur Not yet recruiting
Colmar, France
Principal Investigator: Alexandre KLEIN         
Centre Hospitalier Universitaire Grenoble Recruiting
Grenoble, France
Principal Investigator: Pierre-Louis CARRON         
Centre Hospitalier Départemental Vendée Recruiting
La Roche sur yon, France, 85925
Principal Investigator: Grégoire COUVRAT-DESVERGNES         
Centre Hospitalier La Rochelle Recruiting
La Rochelle, France
Principal Investigator: François POURREAU         
Centre Hospitalier Le Mans Not yet recruiting
Le Mans, France
Principal Investigator: Jean-Philippe COINDRE         
CHRU Lille Not yet recruiting
Lille, France
Principal Investigator: Céline LEBAS         
Centre Hospitalier Universitaire Dupuytren Not yet recruiting
Limoges, France
Principal Investigator: Marie ESSIG         
Centre Hospitalier Lyon Sud Not yet recruiting
Lyon, France
Principal Investigator: Mathilde NOUVIER         
Hopital de la Conception - APHM Not yet recruiting
Marseille, France
Principal Investigator: Noémie JOURDE         
Centre Hospitalier Universitaire Lapeyronie Not yet recruiting
Montpellier, France
Principal Investigator: Ilan SZWARC         
Centre Hospitalier Universitaire de Nantes Recruiting
Nantes, France
Principal Investigator: Fadi FAKHOURI         
Centre Hospitalier Universitaire Nice Not yet recruiting
Nice, France
Principal Investigator: Marine ANDREANI         
Aphp - Bichat Not yet recruiting
Paris, France
Principal Investigator: Eric DAUGAS         
Aphp - Hegp Not yet recruiting
Paris, France
Principal Investigator: Georges-Alexandre KARRAS         
APHP - Henri Mondor Not yet recruiting
Paris, France
Principal Investigator: Khalil EL KAROUI         
Centre Hospitalier Universitaire Poitiers Not yet recruiting
Poitiers, France
Principal Investigator: Frank BRIDOUX         
Centre Hospitalier Quimper Not yet recruiting
Quimper, France
Principal Investigator: Pascale SIOHAN         
Centre Hospitalier Universitaire Rennes Recruiting
Rennes, France
Principal Investigator: Cécile VIGNEAU         
Centre Hospitalier Universitaire Rouen Not yet recruiting
Rouen, France
Principal Investigator: Dominique GUERROT         
Centre Hospitalier Saint-Nazaire Recruiting
Saint Nazaire, France
Principal Investigator: Dominique BESNIER         
Centre Hospitalier Saint Brieuc Not yet recruiting
Saint-Brieuc, France
Principal Investigator: Christophe CHARASSE         
Centre Hospitalier Saint-Malo Not yet recruiting
Saint-Malo, France
Principal Investigator: Eric RENAUDINEAU         
Centre Hospitalier Universitaire Saint Etienne Not yet recruiting
Saint-Étienne, France
Principal Investigator: Christophe MARIAT         
Centre Hospitalier Universitaire Strasbourg Not yet recruiting
Strasbourg, France
Principal Investigator: Bruno MOULIN         
CHRU Bretonneau Not yet recruiting
Tours, France
Principal Investigator: Jean-Michel HALIMI         
Centre Hospitalier Valenciennes Recruiting
Valenciennes, France
Principal Investigator: Claire CARTERY         
Centre Hospitalier Bretagne Atlantique Not yet recruiting
Vannes, France
Principal Investigator: Lise MANDART         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Principal Investigator: Grégoire COUVRAT-DESVERGNES CHD Vendée

Responsible Party: Centre Hospitalier Departemental Vendee Identifier: NCT03323476     History of Changes
Other Study ID Numbers: CHD005-17
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Mycophenolic Acid
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents