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

NCT03635385 | Completed

• 2 other identifiers: 2018-312018-A00510-55
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Failure, Acute

Outcome Measures

Primary Outcomes (1)

• Percent of Anti-glomerular basement membrane anitibodies

  Comparison of anti-glomerular basement membrane anitibodies dosage between the 2 groups

  12 months

Study Arms (2)

Plasma exchange (PE) technic patient group

ACTIVE COMPARATOR

Procedure: Apheresis technics

Immunoadsorption technic patient group

ACTIVE COMPARATOR

Procedure: Apheresis technics

Interventions

Apheresis technics PROCEDURE

Blood draw will be performed for anti bodies dosages

Immunoadsorption technic patient group; Plasma exchange (PE) technic patient group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assisatance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Emilie Garrido

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 17, 2018
• Study Start: January 23, 2019
• Primary Completion: May 22, 2022
• Study Completion: September 1, 2023
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (1)