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)

• ClinicalTrials.gov Identifier: NCT03635385
• Recruitment Status: Recruiting
• First Posted: August 17, 2018
• Last Update Posted: November 19, 2019
• Sponsor: Assistance Publique Hopitaux De Marseille
• Information provided by (Responsible Party): Assistance Publique Hopitaux De Marseille

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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: January 23, 2019
• Estimated Primary Completion Date: January 22, 2022
• Estimated Study Completion Date: September 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

Outcome Measures

Primary Outcome Measures :

1. Percent of Anti-glomerular basement membrane anitibodies [ Time Frame: 12 months ]
   Comparison of anti-glomerular basement membrane anitibodies dosage between the 2 groups

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts

Contact: Noémie JOURDE, MD/PhD; +334 91 38 30 42; noemie.jourde@ap-hm.fr

Locations

France

Assisatance Publique Hôpitaux de Marseille; Recruiting

Marseille, France, 13354

Contact: Noémie Jourde, MD/PhD

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

• Study Director: Emilie Garrido; Assistance Publique Hôpitaux de Marseille

More Information

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT03635385
• Other Study ID Numbers: 2018-31; 2018-A00510-55 ( Other Identifier: Ansm )
• First Posted: August 17, 2018
• Last Update Posted: November 19, 2019
• Last Verified: November 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anti-Glomerular Basement Membrane Disease; Renal Insufficiency; Acute Kidney Injury; Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Kidney Diseases; Urologic Diseases; Vascular Diseases; Cardiovascular Diseases; Systemic Vasculitis; Autoimmune Diseases; Immune System Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Glomerulonephritis; Nephritis