Impact of Anti-HLA Donor-specific Antibodies in ABO-incompatible Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
It was previously suggested an improvement of graft survival in ABO/HLA incompatible kidney transplantation (KT) compared with HLA (human leukocyte antigen) incompatible transplantation. Here, the investigators would analyse clinical, biological and histological results of ABO/HLA incompatible kidney transplant recipients, comparing with ABO or HLA compatible kidney transplantation.

Detailed Description
-----------------
The investigators propose to analyze the clinical, biological and histological course of kidney function, but also to investigate the T and B cells population after KT in ABO incompatible, ABO/HLA incompatible and HLA incompatible kidney transplantation (1 and 7 years posttransplantation in each groups).

Official Title
-----------------
Impact of Anti-HLA Donor-specific Antibodies in ABO-incompatible Kidney Transplantation

Conditions
-----------------
Kidney Transplant

Intervention / Treatment
-----------------
* Other: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient receiving a KT and followed at least one year in Toulouse Hospital Patient who have signed informed consent > 18 years old Exclusion Criteria: Patient under protective measures Patients treated for cancer, infectious or immune disease by molecules that could interfere with lymphocyte populations : Interleukin 6 (IL6) blockers, Programmed cell death 1(PD1) and the cytotoxic T-lymphocyte-associated antigen 4 (CTL4) blockers. Immunosuppressive treatments withdrawal - Patient in chronic dialysis Ongoing pregnancy or pregnancy in the past year Past of splenectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABO/HLA incompatible KT<br>Blood sampling for descriptive analysis of clinical, biological and histological of 12 ABO and HLA incompatible kidney transplantation (KT) | Other: Blood sampling<br>* Descriptive analysis of clinical, biological and histological of 3 arms: ABO incompatible, HLA incompatible, and ABO/HLA incompatible kidney transplantation (1 and 5 years posttransplantation in each groups)<br>|
| Experimental: ABO incompatible KT<br>Blood sampling for descriptive analysis of clinical, biological and histological of 28 ABO incompatible kidney transplantation | Other: Blood sampling<br>* Descriptive analysis of clinical, biological and histological of 3 arms: ABO incompatible, HLA incompatible, and ABO/HLA incompatible kidney transplantation (1 and 5 years posttransplantation in each groups)<br>|
| Experimental: HLA incompatible KT<br>Blood sampling for descriptive analysis of clinical, biological and histological of 20 HLA incompatible kidney transplantation | Other: Blood sampling<br>* Descriptive analysis of clinical, biological and histological of 3 arms: ABO incompatible, HLA incompatible, and ABO/HLA incompatible kidney transplantation (1 and 5 years posttransplantation in each groups)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression related to antibody mediated rejection | To determine expression of genes related to antibody mediated rejection (inflammation, and endothelial cell activation) by transcriptomic analyse (whole genome micro-array) on kidney biopsies | 1 year posttransplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| description of T subsets cells | to analyse of T subsets cells after Kidney transplantation in blood samples of patients by flow cytometry | 1 to 5 years posttransplantation | 
| description of B subsets cells | to analyse of B subsets cells after Kidney transplantation in blood samples of patients by flow cytometry | 1 to 5 years posttransplantation | 
| description of lymphocytes rates | to analyse rates of lymphocytes after Kidney transplantation in blood samples of patients by flow cytometry | 1 to 5 years posttransplantation | 
| Evolution of creatinine clearance | to analyse creatinine clearance in blood samples of patients after kidney transplantation | 1 to 5 years posttransplantation | 
| Evolution of systematic annual kidney biopsies | To analyse the evolution of systematic annual kidney biopsies by microscopy | 1 to 5 years posttransplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complications