Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1

NCT02147210 | Completed

• 2 other identifiers: 13 194 02AOL 2013
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplantation

Keywords

Chronic transplant glomerulopathy; antibody mediated rejection; Ephrin-B1

Outcome Measures

Primary Outcomes (1)

• Expression level of ephrin-B1 in biopsies from kidney transplant

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

  Day 1

Secondary Outcomes (2)

• Level of expression of the gene encoding for ephrin-B1

  Day 1

• Kinetics of expression of ephrin-B1

  Day 1

Study Arms (2)

1-Case

patients who developed CTG secondary to antibody-mediated kidney rejection (AMR), diagnosed by microscopic analysis.

Other: biological analysis

2-Control

patients with antibody-mediated kidney rejection (AMR) but without CTG

Other: biological analysis

Interventions

biological analysis OTHER

1-Case; 2-Control

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

Biopsies from patients corresponding to eligibility criteria (see below) will be selected from the list of kidney transplant patients followed up in the Toulouse University Hospital. They will be divided into two groups matched for age, sex and time of kidney transplantation (n = 30 for each group). Iterative biopsies are conserved in the collection of tissue samples of the CHU

You may qualify if:

• 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

You may not qualify if:

• patient with uncontrolled hypertension - patient with diabetes mellitus -

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Service d'Anatomie Pathologique et Histologie-Cytologie Hôpital Rangueil

Toulouse, 31059, France

Location

MeSH Terms

Interventions

Biological Oxygen Demand Analysis

Intervention Hierarchy (Ancestors)

Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Céline Guilbeau-Frugier, MD

  Service d'Anatomie Pathologique et Histologie-Cytologie,Rangueil Hospital, University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

• Jean-Michel Senard, Md PhD

  Department of Pharmacology,Toulouse University Hospital and INSERM U1048

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 26, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

FR (1)