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

Not Applicable

Completed

• Conditions: Kidney Transplant
• Interventions: Other: Blood sampling

• Registration Number: NCT03423901
• Lead Sponsor: University Hospital, Toulouse

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).

Study Timeline

• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-02-05
• Study Start: 2018-02-06
• Study First Posted: 2018-02-06
• Primary Completion: 2018-05-02
• Study Completion: 2018-05-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HLA incompatible KT	Blood sampling	Blood sampling for descriptive analysis of clinical, biological and histological of 20 HLA incompatible kidney transplantation
ABO/HLA incompatible KT	Blood sampling	Blood sampling for descriptive analysis of clinical, biological and histological of 12 ABO and HLA incompatible kidney transplantation (KT)
ABO incompatible KT	Blood sampling	Blood sampling for descriptive analysis of clinical, biological and histological of 28 ABO incompatible kidney transplantation

Primary Outcome Measures

Name	Time	Method
Gene expression related to antibody mediated rejection	1 year posttransplantation	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Toulouse, France