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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03423901
Acronym
A3
Enrollment
58
Registered
2018-02-06
Start date
2018-02-06
Completion date
2018-05-05
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant

Keywords

Complications

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).

Interventions

OTHERBlood 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)

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gene expression related to antibody mediated rejection1 year posttransplantationTo 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

MeasureTime frameDescription
description of B subsets cells1 to 5 years posttransplantationto analyse of B subsets cells after Kidney transplantation in blood samples of patients by flow cytometry
description of lymphocytes rates1 to 5 years posttransplantationto analyse rates of lymphocytes after Kidney transplantation in blood samples of patients by flow cytometry
description of T subsets cells1 to 5 years posttransplantationto analyse of T subsets cells after Kidney transplantation in blood samples of patients by flow cytometry
Evolution of creatinine clearance1 to 5 years posttransplantationto analyse creatinine clearance in blood samples of patients after kidney transplantation
Evolution of systematic annual kidney biopsies1 to 5 years posttransplantationTo analyse the evolution of systematic annual kidney biopsies by microscopy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026