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Endothelial Microparticules and Antibody Mediated Rejection and Kidney Transplantation: Biomarker of Antibody-mediated Rejection in Kidney Transplantation (MICROMARK RJ)

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ClinicalTrials.gov Identifier: NCT03098238
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.


Condition or disease Intervention/treatment Phase
Renal Transplantation Biological: Biological sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Endothelial Microparticules as Biomarker of Antibody-mediated Rejection in Kidney Transplantation
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patients without humoral rejection or DSA
Renal transplant patients with systematic kidney biopsy at 3 months and 12 months Patients without humoral rejection or DSA (Donor Specific Antibodies)
Biological: Biological sample
Biological sampling of two citrate tubes (18 ml) during a normal blood

Patient without humoral rejection with a DSA
Patient without humoral rejection with a DSA (Donor Specific Antibodies)Patients with a graft biopsy for a donor-specific anti-HLA antibody
Biological: Biological sample
Biological sampling of two citrate tubes (18 ml) during a normal blood

Patients with humoral rejection
Patients with humoral rejection
Biological: Biological sample
Biological sampling of two citrate tubes (18 ml) during a normal blood




Primary Outcome Measures :
  1. Plasma concentration of endothelial microparticles [ Time Frame: 1 day ]
    Endothelial microparticle (MPE) plasma concentration for the diagnosis of humoral rejection in renal transplant patients with DSA.


Secondary Outcome Measures :
  1. Presence of specific MEPs [ Time Frame: 1 day ]
    Presence of MPEs specific to the graft endothelium and to evaluate their diagnostic performance in relation to non-specific MEPs



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years at time of inclusion
  • Renal transplant patients monitored at Montpellier University Hospital
  • With a recent or planned realization of a graft biopsy
  • Patients with DSA (s) detected by Single Antigen Bead Assay (SAB, LabScreen Single Antigen, One Lambda Kit) with an average fluorescence intensity> 500 IU Or Patients without DSA transplanted to a year with a systematic biopsy aspiration.

Exclusion Criteria:

  • Refusal to participate in or to undergo the examination
  • Major protected by guardianship
  • History of treated humoral rejection
  • Incompatible graft ABO
  • Multi-organ transplantation
  • Cardiovascular disease active (myocardial infarction <3 months, arteriopathy obliterating lower limbs stage III or IV)
  • Sepsis in progress
  • Evolving Cancers
  • Lupus nephropathy

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): NCT03098238


Contacts
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Contact: Moglie LE QUINTREC DONNETTE 467338475 ext 33 m-lequintrec-donnette@chu-montpellier.fr

Locations
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France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: MOGLIE LE QUINTREC DONNETTE         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Moglie LE QUINTREC DONNETTE University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03098238    
Other Study ID Numbers: RECHMPL16_0263
UF 9746 ( Other Identifier: Montpellier University Hospital )
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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