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Evaluating the effects of stopping immunosuppressive therapy in patients with ANCA vasculitis and end-stage renal disease

Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease: a Prospective, Multicenter, Randomized, Open-label, Clinical Trial

Phase 3 Interventional Centre Hospitalier Departemental Vendee · NCT03323476

This study is testing if it's safe for people with ANCA vasculitis and end-stage kidney disease to stop their immunosuppressive therapy without increasing their risk of relapse or complications.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment136 (estimated)
Ages18 Years to 90 Years
SexAll
SponsorCentre Hospitalier Departemental Vendee Academic / other
Drugs / interventionsrituximab, cyclophosphamide
Locations57 sites (Amiens and 56 other locations)
Trial IDNCT03323476 on ClinicalTrials.gov

What this trial studies

This prospective randomized trial investigates whether discontinuing immunosuppressive maintenance treatments is safe for patients with ANCA-associated vasculitis (AAV) who have reached end-stage renal disease (ESRD). Participants will be randomly assigned to either stop their immunosuppressive therapy or continue with it. The study aims to assess the risk of AAV relapse and the potential reduction in complications associated with immunosuppression, particularly infections. The main goal is to determine if stopping treatment can be done without exposing patients to excessive risk.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with ANCA-associated vasculitis and end-stage renal disease requiring dialysis.

Not a fit: Patients with severe extra-renal manifestations of AAV or recent active inflammatory lesions in kidney biopsies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer management strategies for patients with ANCA vasculitis and end-stage renal disease, reducing complications from immunosuppressive therapy.

How similar studies have performed: While the approach of discontinuing immunosuppressive therapy in this context is novel, similar studies have shown potential benefits in reducing complications from immunosuppression.

Eligibility criteria

Show full inclusion / exclusion 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 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.

Where this trial is running

Amiens and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
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Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.