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

Study acronym: MASTER-ANCA
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Mar 2031 to Mar 2028
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 58 to 57
    v40
  2. Site contacts updated at 1 of 58 sitesv39
  3. Study sites: 57 to 58v38
  4. Site contacts updated at 1 of 57 sitesv37
  5. Study sites: 56 to 57v36
Show 34 earlier versionsHide 34 earlier versions
  1. Study sites: 55 to 56v35
  2. Re-verified, no change to tracked fieldsv34
  3. Site contacts updated at 1 of 55 sitesv33
  4. Site details revised at 2 of 55 sitesv32
  5. Study sites: 54 to 55v31
  6. Site details revised at 3 of 54 sitesv30
  7. Site details revised at 1 of 54 sitesv29
  8. Study sites: 53 to 54v28
  9. Site details revised at 1 of 53 sitesv27
  10. Primary and study completion dates: Mar 2024 to Mar 2031
    • Study sites: 52 to 53
    • Eligibility criteria shortened, about 7 words
    v26
  11. Site details revised at 1 of 52 sitesv25
  12. Study sites: 51 to 52v24
  13. Study sites: 50 to 51v23
  14. Site contacts updated at 2 of 50 sitesv22
  15. Site details revised at 1 of 50 sitesv21
  16. Study sites: 49 to 50v20
  17. Primary and study completion dates: Feb 2024 to Mar 2024v19
  18. Site details revised at 1 of 49 sitesv18
  19. Study sites: 46 to 49v17
  20. Site details revised at 1 of 46 sitesv16
  21. Site details revised at 1 of 46 sitesv15
  22. Study sites: 44 to 46v14
  23. Eligibility criteria expanded, about 9 wordsv13
  24. Site details revised at 1 of 44 sitesv12
  25. Site details revised at 4 of 44 sitesv11
  26. Study sites: 43 to 44v10
  27. Site details revised at 1 of 43 sitesv9
  28. Study sites: 35 to 43
    • Eligibility criteria expanded, about 34 words
    v8
  29. Site details revised at 3 of 35 sitesv7
  30. Site details revised at 1 of 35 sitesv6
  31. Primary and study completion dates: Feb 2020 to Feb 2024v5
  32. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jan 2020 to Feb 2020
    • Start date changed from estimate of Jan 2018 to Feb 2, 2018
    • Site details revised at 35 of 35 sites
    v4
  33. Re-verified, no change to tracked fieldsv3
  34. Study sites: 34 to 35v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03323476
Lead Sponsor Centre Hospitalier Departemental Vendee
Conditions
(from sponsor)		 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, End Stage Renal Disease
Related terms Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Kidney Failure, Chronic
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov