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

Kidney Failure, Acute Clinical Trial

— CINEVAS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03635385
• Other study ID #: 2018-31
• Secondary ID: 2018-A00510-55
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Noémie JOURDE, MD/PhD
• Phone: +334 91 38 30 42
• Email: noemie.jourde[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2023
• Est. primary completion date: May 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Anti-Glomerular Basement Membrane Disease
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Kidney Failure, Acute
• Renal Insufficiency
• Vasculitis

Intervention

Procedure:
• Apheresis technics
Blood draw will be performed for anti bodies dosages

Locations

Country	Name	City	State
France	Assisatance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Anti-glomerular basement membrane anitibodies	Comparison of anti-glomerular basement membrane anitibodies dosage between the 2 groups	12 months