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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier Universitaire Amiens
  Amiens, France Recruiting
• CHU Angers
  Angers, France Recruiting
• Centre Hospitalier ARRAS
  Arras, France Recruiting
• Centre Hospitalier Avignon
  Avignon, France Recruiting
• Centre Hospitalier Boulogne sur Mer
  Boulogne-sur-Mer, France Recruiting
• Centre Hospitalier Universitaire de Brest
  Brest, France Recruiting

+7 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Grégoire COUVRAT-DESVERGNES — CHD Vendée
• Study coordinator: Chloé MOREAU
• Email: chloe.moreau@chd-vendee.fr
• Phone: 0251446572

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.