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)
Primary Purpose
Kidney Failure, Acute
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Apheresis technics
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure, Acute
Eligibility 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
Sites / Locations
- Assisatance Publique Hôpitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Plasma exchange (PE) technic patient group
Immunoadsorption technic patient group
Arm Description
Outcomes
Primary Outcome Measures
Percent of Anti-glomerular basement membrane anitibodies
Comparison of anti-glomerular basement membrane anitibodies dosage between the 2 groups
Secondary Outcome Measures
Full Information
NCT ID
NCT03635385
First Posted
August 14, 2018
Last Updated
March 22, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03635385
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
May 22, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Plasma exchange (PE) technic patient group
Arm Type
Active Comparator
Arm Title
Immunoadsorption technic patient group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Apheresis technics
Intervention Description
Blood draw will be performed for anti bodies dosages
Primary Outcome Measure Information:
Title
Percent of Anti-glomerular basement membrane anitibodies
Description
Comparison of anti-glomerular basement membrane anitibodies dosage between the 2 groups
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noémie JOURDE, MD/PhD
Phone
+334 91 38 30 42
Email
noemie.jourde@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Garrido
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assisatance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noémie Jourde, MD/PhD
12. IPD Sharing Statement
Learn more about this trial
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
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