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

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ClinicalTrials.gov Identifier: NCT03323476
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : October 22, 2019
Sponsor:
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

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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


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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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 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 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
  • 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.

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

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Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Principal Investigator: Grégoire COUVRAT-DESVERGNES CHD Vendée

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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT03323476     History of Changes
Other Study ID Numbers: CHD005-17
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases
Systemic Vasculitis
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Prednisone
Rituximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
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