Impact of Anti-HLA Donor-specific Antibodies in ABO-incompatible Kidney Transplantation (A3)

August 19, 2019 updated by: University Hospital, Toulouse
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABO/HLA incompatible KT
Blood sampling for descriptive analysis of clinical, biological and histological of 12 ABO and HLA incompatible kidney transplantation (KT)
Other: Blood sampling
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)
Experimental: ABO incompatible KT
Blood sampling for descriptive analysis of clinical, biological and histological of 28 ABO incompatible kidney transplantation
Other: Blood sampling
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)
Experimental: HLA incompatible KT
Blood sampling for descriptive analysis of clinical, biological and histological of 20 HLA incompatible kidney transplantation
Other: Blood sampling
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene expression related to antibody mediated rejection
Time Frame: 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
1 year posttransplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
description of T subsets cells
Time Frame: 1 to 5 years posttransplantation
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
Time Frame: 1 to 5 years posttransplantation
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
Time Frame: 1 to 5 years posttransplantation
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
Time Frame: 1 to 5 years posttransplantation
to analyse creatinine clearance in blood samples of patients after kidney transplantation
1 to 5 years posttransplantation
Evolution of systematic annual kidney biopsies
Time Frame: 1 to 5 years posttransplantation
To analyse the evolution of systematic annual kidney biopsies by microscopy
1 to 5 years posttransplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Arnaud DEL BELLO, MD PhD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2018

Primary Completion (Actual)

May 2, 2018

Study Completion (Actual)

May 5, 2018

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC31/17/0426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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