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

Kidney Transplant Clinical Trial

— A3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423901
• Other study ID #: RC31/17/0426
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Kidney Transplant

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