NCT03423901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 6, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2018

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

January 19, 2018

Last Update Submit

August 19, 2019

Conditions

Kidney Transplant

Keywords

Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • description of T subsets cells

    1 to 5 years posttransplantation

  • description of B subsets cells

    1 to 5 years posttransplantation

  • description of lymphocytes rates

    1 to 5 years posttransplantation

  • Evolution of creatinine clearance

    1 to 5 years posttransplantation

  • Evolution of systematic annual kidney biopsies

    1 to 5 years posttransplantation

Study Arms (3)

ABO/HLA incompatible KT

EXPERIMENTAL

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

Other: Blood sampling

ABO incompatible KT

EXPERIMENTAL

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

Other: Blood sampling

HLA incompatible KT

EXPERIMENTAL

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

Other: Blood sampling

Interventions

Blood samplingOTHER

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 KTABO/HLA incompatible KTHLA incompatible KT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient receiving a KT and followed at least one year in Toulouse Hospital
  • Patient who have signed informed consent
  • \> 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Toulouse, 31059, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Arnaud DEL BELLO, MD PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

February 6, 2018

Study Start

February 6, 2018

Primary Completion

May 2, 2018

Study Completion

May 5, 2018

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)