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

NCT ID: NCT03423901

Last Updated: 2019-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-06

Study Completion Date

2018-05-05

Brief Summary

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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

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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).

Conditions

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Kidney Transplant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ABO/HLA incompatible KT

Blood sampling for descriptive analysis of clinical, biological and histological of 12 ABO and HLA incompatible kidney transplantation (KT)

Group Type EXPERIMENTAL

Blood sampling

Intervention Type 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)

ABO incompatible KT

Blood sampling for descriptive analysis of clinical, biological and histological of 28 ABO incompatible kidney transplantation

Group Type EXPERIMENTAL

Blood sampling

Intervention Type 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)

HLA incompatible KT

Blood sampling for descriptive analysis of clinical, biological and histological of 20 HLA incompatible kidney transplantation

Group Type EXPERIMENTAL

Blood sampling

Intervention Type 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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud DEL BELLO, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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RC31/17/0426

Identifier Type: -

Identifier Source: org_study_id

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