Status:
RECRUITING
Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease
Lead Sponsor:
Centre Hospitalier Departemental Vendee
Conditions:
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
End Stage Renal Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
This prospective randomized trial aims to evaluate the feasibility, risk and benefit of the discontinuation of immunosuppressive maintenance treatments in AAV (Antineutrophil Cytoplasmic Autoantibodie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2031
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT03323476
Start Date
February 2 2018
End Date
March 1 2031
Last Update
November 25 2025
Active Locations (58)
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1
Centre Hospitalier Universitaire Amiens
Amiens, France
2
CHU Angers
Angers, France
3
Centre Hospitalier Angoulême
Angoulême, France
4
Centre Hospitalier ARRAS
Arras, France