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)

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Enrolling

Conditions

Kidney Failure, Acute

Treatments

Procedure: Apheresis technics

Study type

Interventional

Funder types

Other

Identifiers

NCT03635385
2018-31
2018-A00510-55 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Plasma exchange (PE) technic patient group
Active Comparator group
Treatment:
Procedure: Apheresis technics
Immunoadsorption technic patient group
Active Comparator group
Treatment:
Procedure: Apheresis technics

Trial contacts and locations

1

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Central trial contact

Noémie JOURDE, MD/PhD

Data sourced from clinicaltrials.gov

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