CompletedNot Applicable

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

France40 participantsStarted 2019-01-23

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Exclusion Criteria: * Pregnancy or breastfeeding * Vasculitis without anti-MPO, anti-PR3 or anti-MBG * Severe anemia (hemoglobin \<7 g / dL) contraindicates additional blood sampling

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of Anti-glomerular basement membrane anitibodies

Timeframe: 12 months

Trial details

NCT IDNCT03635385

SponsorAssistance Publique Hopitaux De Marseille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-22

View on ClinicalTrials.gov More Kidney Failure, Acute trials