Maintaining or Stopping immunosuppressive Therapy in patients with ANCA vasculitis and End-stage Renal disease: a prospective, multicenter, randomized, open-label, clinical trial

Recruiting

• Conditions: ANCA vasculitis; End-stage Renal disease

• Registration Number: 2024-512470-10-00
• Lead Sponsor: Centre Hospitalier Departemental Vendee

Brief Summary

The study's main objective is to demonstrate the 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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-04-09
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 136

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

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

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 received 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary end point will be the time between randomization and the first severe prejudicial event (severe infection, major AAV relapse, death) during 24 months of follow-up.		The primary end point will be the time between randomization and the first severe prejudicial event (severe infection, major AAV relapse, death) during 24 months of follow-up.

Trial Locations

Locations (56)

Centre Hospitalier Universitaire D'Angers; 🇫🇷 Angers, France

Centre Hospitalier Bretagne Atlantique; 🇫🇷 Vannes, France

Centre Hospitalier Le Mans; 🇫🇷 Le Mans Cedex 9, France

AUB SANTE LORIENT; 🇫🇷 LORIENT, France

Les Hopitaux Universitaires De Strasbourg; 🇫🇷 Strasbourg Cedex, France

Hopital NOVO; 🇫🇷 Pontoise, France

Centre Hospitalier Universitaire De Poitiers; 🇫🇷 Poitiers, France

Centre Hospitalier Universitaire De Nice; 🇫🇷 Nice, France

Centre Hospitalier Departemental Vendee; 🇫🇷 La Roche Sur Yon Cedex 9, France

Hopital Henri Mondor - 1 rue Gustave Eiffel; 🇫🇷 Créteil, France

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Centre Hospitalier Universitaire D'Angers

🇫🇷Angers, France

Jean François AUGUSTO

Site contact

+33241353637

JFAugusto@chu-angers.fr