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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)

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ClinicalTrials.gov Identifier: NCT03635385
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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

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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
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635385


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

Locations
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France
Assisatance Publique Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: Noémie Jourde, MD/PhD         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Emilie Garrido Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03635385     History of Changes
Other Study ID Numbers: 2018-31
2018-A00510-55 ( Other Identifier: Ansm )
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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

Additional relevant MeSH terms:
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Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Renal Insufficiency
Acute Kidney Injury
Anti-Glomerular Basement Membrane Disease
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases
Immune System Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Glomerulonephritis
Nephritis
Antibodies
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs