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

This study is not yet open for participant recruitment.
Verified October 2017 by Centre Hospitalier Departemental Vendee
Sponsor:
ClinicalTrials.gov Identifier:
NCT03323476
First Posted: October 27, 2017
Last Update Posted: November 14, 2017
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.
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee
  Purpose

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 Intervention 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
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Departemental Vendee:

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. [ Time Frame: During the 24 months of follow-up ]
    Severe prejudicial event is defined by the occurrence of: severe infection, major AAV relapse, death


Estimated Enrollment: 136
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03323476


Contacts
Contact: Chloé MOREAU 0251446572 chloe.moreau@chd-vendee.fr

Locations
France
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 Not yet 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 Not yet recruiting
Grenoble, France
Principal Investigator: Pierre-Louis CARRON         
Centre Hospitalier Départemental Vendée Not yet recruiting
La Roche sur yon, France, 85925
Principal Investigator: Grégoire COUVRAT-DESVERGNES         
Centre Hospitalier La Rochelle Not yet 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 Not yet 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 Not yet recruiting
Rennes, France
Principal Investigator: Cécile VIGNEAU         
Centre Hospitalier Universitaire Rouen Not yet recruiting
Rouen, France
Principal Investigator: Dominique GUERROT         
Centre Hospitalier Saint-Nazaire Not yet 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 Not yet 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
Investigators
Principal Investigator: Grégoire COUVRAT-DESVERGNES CHD Vendée
  More Information

Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT03323476     History of Changes
Other Study ID Numbers: CHD005-17
First Submitted: October 13, 2017
First Posted: October 27, 2017
Last Update Posted: November 14, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Vasculitis
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
Rituximab
Mycophenolic Acid
Prednisone
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
Glucocorticoids
Hormones