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Completed

NCT Number: NCT03423901

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

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.

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Key information

Conditions

Kidney Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Toulouse, 31059, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Evolution of creatinine clearance

    Time frame: 1 to 5 years posttransplantation

    to analyse creatinine clearance in blood samples of patients after kidney transplantation

  5. Evolution of systematic annual kidney biopsies

    Time frame: 1 to 5 years posttransplantation

    To analyse the evolution of systematic annual kidney biopsies by microscopy

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: A3

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2018
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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