Skip to main content
OpenTrials
Completed

NCT Number: NCT02147210

Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1

The principal purpose is the study of the regulation of the expression of ephrin-B1 by immunofluorescence in kidney biopsies of patients with Chronic transplant glomerulopathy (CTG) compared to biopsies prior to the CTG, in same patients. Level of fluorescence in CTG biopsy will be the experimental reference value.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Anatomie Pathologique et Histologie-Cytologie Hôpital Rangueil

Toulouse, 31059, France

About this study

Chronic transplant glomerulopathy (CTG) is a specific lesion of kidney transplantation and a poor prognostic factor affecting transplant survival. Diagnosis remains only microscopic and lesions are irreversible. Recent studies prove that there is a strong correlation between CTG and antibody mediated rejection (AMR) with a possible link with chronic aggression of the endothelial cell. However, for unknown reason, all AMR does not lead to a CTG. Our recent data on mice demonstrated that ephrin-B1 is expressed in the glomerular endothelial cells and knockout mice for the gene encoding ephrin-B1 develop progressively ultrastructural glomerular lesions close to modifications observed in CTG, as well as proteinuria and chronic renal failure, suggesting that ephrin B1 could participate to CTG. Moreover, in a preliminary study on human kidney transplant biopsy we observed decrease in ephrin-B1 immunofluorescence on glomerulus when CTG, even in low grade. These data, and ultrastructural modifications in Knock Out (KO) mice suggest that early regulation of kidney expression of ephrin-B1 in the glomerulus may occur during the process leading to the CTG as antibody-mediated kidney rejection (AMR).

The purpose of the study is to determinate if ephrin-B1 expression is modified in CTG.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Kidney transplant patient for whom renal biopsies are stored in the "collection of the University Hospital Toulouse" (collection N° DC-2009-989) and who received information on the purpose of the study, use of biopsies and who has not manifested any opposition.
  • Kidney transplant patient with iterative biopsies with at least: post-surgery biopsy D0 (or early post-transplant biopsy D7 and at least one biopsy protocol. - Age> 18 years Case group: - Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR progressing to CTG between 2006 and 2013. Control group: - Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR without progressing to CTG between 2006 and 2013

Exclusion criteria

  • patient with uncontrolled hypertension - patient with diabetes mellitus -
  • patient treated or who was treated with mTOR inhibitor - recurrence of the initial glomerular pathology - de novo glomerulopathy - patient including in another study with an exclusion period still going

Treatment and study plan

Biological analysis

Other

Primary outcomes

  1. Expression level of ephrin-B1 in biopsies from kidney transplant

    Time frame: Day 1

    Analysis on all biopsies available from transplantation to Chronic transplant glomerulopathy by immunofluorescence (by anti-C4d)

Secondary outcomes

  1. Level of expression of the gene encoding for ephrin-B1

    Time frame: Day 1

    Analysis on all biopsies available from transplantation to Chronic transplant glomerulopathy by quantitative PCR (qPCR) and normalized to the expression of the gene encoding for GAPDH

  2. Kinetics of expression of ephrin-B1

    Time frame: Day 1

    Analysis on all biopsies available from transplantation to CTG by quantitative PCR (qPCR) and normalized to the expression of the gene encoding for GAPDH

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: GARRE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 26, 2014
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.