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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03423901
Other study ID # RC31/17/0426
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 6, 2018
Est. completion date May 5, 2018

Study information

Verified date August 2019
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date May 5, 2018
Est. primary completion date May 2, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
France University Hospital Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary Evolution of creatinine clearance to analyse creatinine clearance in blood samples of patients after kidney transplantation 1 to 5 years posttransplantation
Secondary Evolution of systematic annual kidney biopsies To analyse the evolution of systematic annual kidney biopsies by microscopy 1 to 5 years posttransplantation
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