Subclass of Donor-specific Antibody as a Risk Factor of Antibody Mediated Rejection in Renal Transplantation

NCT04026087 | Completed

• 1 other identifier: RECHMPL18_0455 UF7724
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Antibody-mediated rejection is now recognized as the first cause of long-term kidney transplant loss. This type of rejection is mediated by the presence of graft-specific antibodies, usually directed against HLA (Human Leukocyte Antigens), called DSA (Donor Specific Antibody). De novo DSA (ie, post-transplantation) is detected in approximately 20% of transplant recipients in the first five years, and is a major risk factor for antibody mediated rejection and graft loss. All anti-HLA antibodies therefore do not have the same pathogenicity. Some teams have shown that the detection of IgG3 anti-HLA by cytometry is associated with a higher risk of humoral rejection but these results have not been confirmed by others. One of the limitations of the cytometry by Luminex technique is that it only informs the detection of each subclass but does not allow analysis of the distribution of the different subclasses of a DSA. A method has been developed for the relative detection and quantification of different subclasses of the DSA using the mass spectrometry technique and will be tested during this study. This new quantification method therefore opens up the prospect of studying whether, not only the presence but especially the distribution of IgG subclasses, in particular IgG3, could constitute a reliable and robust marker of humoral rejection.

Conditions

Antibody-mediated Rejection

Keywords

Renal transplantation; antibody-mediated rejection; DSA; mass spectrometry technique

Outcome Measures

Primary Outcomes (1)

• distribution of DSA IgG subclasses

  the performance of the distribution of DSA IgG subclasses for the diagnosis of humoral rejection in renal transplant patients with Donor Specific Antibodies

  day 0 (inclusion visit)

Secondary Outcomes (3)

• histological criteria for humoral rejection

  day 0 (inclusion visit)

• degradation of graft function

  1 year after inclusion of subjects

• graft loss

  1 year after inclusion of subjects

Study Arms (1)

patient with kidney transplant

Blood sample will be took from subjects during this research

Eligibility Criteria

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

Study Population

Patients 18 years old and over with kidney transplant and who have DSA

You may qualify if:

• \- Patients over 18 years old
• Renal transplant patients followed at the University Hospital of Montpellier presenting a DSA de novo during follow-up.
• Affiliation or beneficiary of a social security scheme.
• Patients who consented to the collection of a plasma sample on graft biopsy day and use in future programs (Collection DC-2014-2328)
• Collection of non-opposition to participate in the study
• Eligible for graft biopsy for humoral-mediated rejection (according to Banff 2015 classification) (Appendix 1)
• Collection of non-opposition to participate in the study
• Signature of informed consent to participate in the collection of a plasma sample on graft biopsy day and use in future programs (Collection DC-2014-2328)

You may not qualify if:

• Pregnant or lactating women according to Article L1121 5 of the health public Code
• Vulnerable persons according to article L1121-6 of the health public Code
• Major persons placed under guardianship or curator

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

CHU Lapeyronie

Montpellier, Hérault, 34090, France

Location

Related Publications (2)

• Pernin V, Bec N, Beyze A, Bourgeois A, Szwarc I, Champion C, Chauvin A, Rene C, Mourad G, Merville P, Visentin J, Perrochia H, Couzi L, Larroque C, Le Quintrec M. IgG3 donor-specific antibodies with a proinflammatory glycosylation profile may be associated with the risk of antibody-mediated rejection after kidney transplantation. Am J Transplant. 2022 Mar;22(3):865-875. doi: 10.1111/ajt.16904. Epub 2021 Dec 18.

  PMID: 34863025 RESULT

• Pernin V, Beyze A, Szwarc I, Bec N, Salsac C, Perez-Garcia E, Mourad G, Merville P, Visentin J, Perrochia H, Larroque C, Couzi L, Le Quintrec M. Distribution of de novo Donor-Specific Antibody Subclasses Quantified by Mass Spectrometry: High IgG3 Proportion Is Associated With Antibody-Mediated Rejection Occurrence and Severity. Front Immunol. 2020 Jun 2;11:919. doi: 10.3389/fimmu.2020.00919. eCollection 2020.

  PMID: 32670261 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

Study Officials

• Vincent Pernin, Doctor

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 19, 2019
• Study Start: July 18, 2019
• Primary Completion: May 6, 2022
• Study Completion: February 15, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

FR (1)