CINEVAS: 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

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Recruiting

CT.gov ID

NCT03635385

Collaborator

(none)

Enrollment

Location

Arms

55.3

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Acute	Procedure: Apheresis technics	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 23, 2019

Anticipated Primary Completion Date :

May 22, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Plasma exchange (PE) technic patient group	Procedure: Apheresis technics Blood draw will be performed for anti bodies dosages
Active Comparator: Immunoadsorption technic patient group	Procedure: Apheresis technics Blood draw will be performed for anti bodies dosages

Arm

Intervention/Treatment

Active Comparator: Plasma exchange (PE) technic patient group

Procedure: Apheresis technics

Blood draw will be performed for anti bodies dosages

Active Comparator: Immunoadsorption technic patient group

Procedure: Apheresis technics

Blood draw will be performed for anti bodies dosages

Outcome Measures

Primary Outcome Measures

Percent of Anti-glomerular basement membrane anitibodies [12 months]
Comparison of anti-glomerular basement membrane anitibodies dosage between the 2 groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assisatance Publique Hôpitaux de Marseille	Marseille		France	13354

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: Emilie Garrido, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT03635385

Other Study ID Numbers:

2018-31
2018-A00510-55

First Posted:

Aug 17, 2018

Last Update Posted:

Mar 23, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anti-Glomerular Basement Membrane Disease

Renal Insufficiency

Acute Kidney Injury

Vasculitis

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Study Results

No Results Posted as of Mar 23, 2022