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Endothelial Microparticules and Antibody Mediated Rejection and Kidney Transplantation: Biomarker of Antibody-mediated Rejection in Kidney Transplantation

NCT03098238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2022-12-14

No results posted yet for this study

Summary

Context and rationale:

Antibody-mediated rejection is the leading cause of long-term renal graft loss. It's due to the production by the recipient of antibodies directed against antigens (belonging or not to the HLA system) present on the surface of the donor specific endothelial cells (DSA), leading to graft failure.

The main difficulty to manage the humoral rejection is the delay of the diagnosis and the treatment to slow the evolution towards fibrosis.

Positivity of anti-HLA antibodies is the main risk factor for the rejection but the only way to make the diagnosis of humoral rejection is to perform a graft biopsy, an invasive process.

Endothelial microparticles (MPE) are small membrane vesicles generated by endothelial cell activation and / or apoptosis processes.

We test the hypothesis that endothelial microparticles are an early diagnostic biomarker of humoral rejection in renal transplantation allowing to detect it at the "subclinical" stage.

Primary and secondary objectives:

The main objective of this study is to estimate the performance of MPE plasma concentration for the diagnosis of humoral rejection in renal transplant patients with DSA. The secondary objective is to investigate by mass spectrometry the MPEs specific to the endothelium of the graft and to evaluate their diagnostic performance in relation to non-specific MEPs

Methodology :

We will conduct a cross-sectional evaluation of a diagnostic method from a collection of biological samples. The gold standard for the diagnosis of humoral rejection is the histological diagnosis on graft biopsy. The new test under study will be the flow cytometric assay of the MPE concentration carried out on plasma taken on the day of the graft biopsy.

Feasibility:

Among the active list of renal transplant patients attending the Montpellier University Hospital, we estimate that we can include the number of subjects required (N = 250) over 18 months. This work will be carried out in a laboratory with all the tools and techniques used, in particular flow cytometry and mass spectrometry, perfectly mastered and realized on dedicated technical platforms

Benefits / Outlook:

find a non-invasive early diagnostic biomarker to detect humoral rejection from the "subclinical" stage in order to set up an adapted treatment as quickly as possible.

Conditions

  • Renal Transplantation

Interventions

BIOLOGICAL

Biological sample

Biological sampling of two citrate tubes (18 ml) during a normal blood

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Moglie LE QUINTREC DONNETTE · University Hospital, Montpellier

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2020-06-04
Completion
2020-06-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03098238 on ClinicalTrials.gov