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.|
|ClinicalTrials.gov Identifier: NCT03323476|
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : October 22, 2019
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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®
- 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
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
|Contact: Chloé MOREAUemail@example.com|
Show 49 Study Locations
|Principal Investigator:||Grégoire COUVRAT-DESVERGNES||CHD Vendée|