End-stage renal disease ANCA vascularitis Immunosuppressive therapy
Conditions
Interventions
Trade Name: Imurel 25 mg
Pharmaceutical Form: Coated tablet
Trade Name: MABTHERA 100mg
Pharmaceutical Form: Solution for injection
Trade Name: Cellcept
Pharmaceutical Form: Coated tablet
Trade Nam
Sponsors
Centre Hospitalier Départemental Vendée de la Roche sur Yon
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 90 years - Patients under guardianship or trusteeship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: The second objectives are to assess: - The incidence of death. - The incidence of major and minor AAV relapses, - The incidence of infectious episodes - The incidence and evolution of haemotologic disorders (neutropenia, lymphopenia) and of peripheral blood lymphocyte phenotyping (CD3+, CD4+, CD8+, CD19+) and their impact on infectious episodes occurrence. - The incidence of neoplasia. - The evolution in AAV patients reaching ESRD the vasculitis activity assessed using the usual scores (BVAS/WG and VDI). ;Primary end point(s): The primary end point will be the time between inclusion and the first severe prejudicial event defined by the occurrence of a major AAV relapse, or severe infection or death during 24 months of follow-up. Major relapse will be defined according to current European guidelines (EULAR), and severe infection as infection requiring admission to hospital. ;Timepoint(s) of evaluation of this end point: during 24 months of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will be: - The time between inclusion and any major relapse that required specific treatment. - The time between inclusion and any minor relapse of vasculitis. - The time between baseline and the patient's death. - The time between inclusion and the first infection requiring specific care. - Rates of moderate ( 0.3G / L) lymphopenia diagnosed on routine follow-up blood tests performed in ESRD patients. - Rates of neutropenia (<1.5 G / L) and severe neutropenia (<0.8 G / L) diagnosed on routine follow-up blood tests performed. - Rates of level of CD3+, CD4+, CD8+, CD19+ quantified on routine surveillance biological samples. - The time between inclusion and the diagnosis of neoplasia. - The evolution of the Birmingham Vasculitis Activity Score for Wegener’s granulomatosis evaluation form (BVAS/ WG): at inclusion and every 6 months during follow-up - The evolution of the Vasculitis Damage Index (VDI) score (score of organ damage that has occurred in patients since the onset of vasculitis), during follow-up: at inclusion and every 6 months during follow-up ;Timepoint(s) of evaluation of this end point: during 24 months of follow-up | — |
Countries
France
Contacts
Public ContactChloé MOREAU
Centre Hospitalier Départemental Vendée
Outcome results
None listed