Informations générales (source: ClinicalTrials.gov)
Comparison of ANCA and Anti-GBM Auto-antibodies Removal Kinetics Between Plasma Exchanges and Immunoadsorption in Patients With ANCA-associated Vasculitis or Anti-GBM Disease (CINEVAS)
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
janvier 2019
septembre 2023
29 juin 2024
Anti-neutrophil cytoplasmic antibodies (ANCA), directed against myeloperoxidase (MPO) and
against proteinase 3 (PR3), have a pathogenic role during ANCA (AAV) vasculitis.
Glomerular basement membrane (MBG) antibodies also have a direct pathogenic role in
Goodpasture's syndrome and anti-MBG antibody glomerulonephritis (GN). In some patients,
the severity of renal and / or pulmonary involvement justifies the rapid purification of
these autoantibodies by an apheresis procedure, while waiting for the effect of
immunosuppressive treatments aimed at reducing their production. During vasculitis,
plasma exchange (PE) is recommended in patients with severe renal impairment or
intra-alveolar hemorrhage (2012 KDIGO Clinical Practice Guideline for
Glomerulonephritis).
Given certain disadvantages related to plasma exchanges (low volume of purified plasma,
non-selective technique for immunoglobulins (Ig), need for replacement solute, induction
of coagulation disorders), immunoadsorption (IA), already used in transplantation, has
been developed in these indications. IA has indeed greater selectivity for Ig with a
probable better purification capacity due to higher volumes of plasma treated per
session. The price of IA is however higher than that of EP.
These two apheresis techniques, EP and IA, are commonly used in France during severe
forms of vasculitis ANCA or anti-MBG, without the superiority of one or the other has
been demonstrated. As a result of higher plasma volumes being purified, AI may allow
faster purification of pathogenic antibodies. No studies to date have specifically
compared the purification kinetics of these antibodies between EP and IA.
The CINEVAS study (VAScularite Antibody Purification CINetic) is a multicentric pilot
study whose main objective is to compare the purification kinetics of ANCA (anti-MPO or
anti-PR3) and / or anti- MBG in patients treated with EP versus those treated with IA
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Assisatance Publique Hôpitaux de Marseille - 13354 - Marseille - France | Noémie Jourde, MD/PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age ≥ 18 years
- Patient with ANCA vasculitis with positive anti-MPO or anti-PR3 antibodies, or
patient with Goodpasture syndrome or anti-MBG antibody glomerulonephritis
- Patient for whom the investigating physician retains the indication of apheresis
- Induction treatment with corticosteroids and cyclophosphamide or rituximab
- Age ≥ 18 years
- Patient with ANCA vasculitis with positive anti-MPO or anti-PR3 antibodies, or
patient with Goodpasture syndrome or anti-MBG antibody glomerulonephritis
- Patient for whom the investigating physician retains the indication of apheresis
- Induction treatment with corticosteroids and cyclophosphamide or rituximab
- Pregnancy or breastfeeding
- Vasculitis without anti-MPO, anti-PR3 or anti-MBG
- Severe anemia (hemoglobin <7 g / dL) contraindicates additional blood sampling