Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1 (GARRE)
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| ClinicalTrials.gov Identifier: NCT02147210 |
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Recruitment Status :
Completed
First Posted : May 26, 2014
Last Update Posted : March 7, 2017
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| Condition or disease | Intervention/treatment |
|---|---|
| Kidney Transplantation | Other: biological analysis |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 60 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1 |
| Study Start Date : | September 2013 |
| Actual Primary Completion Date : | December 2016 |
| Actual Study Completion Date : | December 2016 |
| Group/Cohort | Intervention/treatment |
|---|---|
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1-Case
patients who developed CTG secondary to antibody-mediated kidney rejection (AMR), diagnosed by microscopic analysis.
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Other: biological analysis |
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2-Control
patients with antibody-mediated kidney rejection (AMR) but without CTG
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Other: biological analysis |
- 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)
- 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
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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): NCT02147210
| France | |
| Service d'Anatomie Pathologique et Histologie-Cytologie Hôpital Rangueil | |
| Toulouse, France, 31059 | |
| Principal Investigator: | Céline Guilbeau-Frugier, MD | Service d'Anatomie Pathologique et Histologie-Cytologie,Rangueil Hospital, University Hospital of Toulouse | |
| Study Director: | Jean-Michel Senard, Md PhD | Department of Pharmacology,Toulouse University Hospital and INSERM U1048 |
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT02147210 |
| Other Study ID Numbers: |
13 194 02 AOL 2013 ( Other Grant/Funding Number: University Hospital Toulouse ) |
| First Posted: | May 26, 2014 Key Record Dates |
| Last Update Posted: | March 7, 2017 |
| Last Verified: | March 2017 |
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Chronic transplant glomerulopathy antibody mediated rejection Ephrin-B1 |