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

Phase 1

Conditions: End-stage renal diseaseANCA vascularitisImmunosuppressive therapy
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2017-000390-37-FR

Lead Sponsor: Centre Hospitalier Départemental Vendée de la Roche sur Yon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 136

Inclusion Criteria

The inclusion criteria are:
-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 who gave written informed consent for participation in the study.
- Patients with affiliation to the French social security system

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 86

Exclusion Criteria

The non-inclusion criteria are:
-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) 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.
-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 positive anti-glomerular basement membrane antibodies.
-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
-Inability to understand and sign the informed consent
- Pregnant women
- Age < 18 years or > 90 years
- Patients under guardianship or trusteeship