About this trial
This is a comparative, prospective, non-interventional study to evaluate immune response in patients with chronic kidney disease. The primary objective is to define immunodeficiency (phenotype and function of T cells) in patients with end-stage kidney disease. The second objective is to provide an in-vitro proof-of-concept of T-cell engineering in the context of end-stage kidney disease.
The study population was patients with chronic kidney disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female ≥ 18 years
Informed participants who did not object to participating in the study
Disqualifiers
Chronic progressive infections
Prior organ transplantation (including bone marrow transplantation)
Previous treatment with immunosuppressive agents (such as Rituximab, Eculizumab, Tacrolimus or Ciclosporin, Cellcept or Imurel) within 2 years prior to inclusion
Participant under guardianship, curatorship or deprived of liberty
Trial population
Patients with chronic kidney disease followed in Nephrology department of Orléans University Hospital (CHU d'Orléans): group 1 : end-stage kidney disease and group 2 : stage 3 chronic kidney disease Healthy donors in Etablissement français du Sang (EFS) in Orleans: Group 3 : healthy donors
Trial design
Case-control
Prospective
Treatments tested in this trial
1 blood sample for each participant
Other interventionBlood sample for cohort n°1 and n°2 (collection during a peripheral venous blood sample, part of the standard of care for this disease) : 1 blood sample for each patient 28mL of blood (4 tubes, 7mL per tube) Blood samples for cohort n°3 (collection during blood donation at Etablissement Français du Sang) : 1 blood sample for each healthy donor 14mL of blood (2 tubes, 7mL per tube)
Treatment groups
Trial outcomes
Primary outcomes
The primary outcome is to characterize T cell immunodeficiency in our cohort of end-stage kidney disease patients from a phenotypic and functional point of view.
Identify T cells and perform extensive phenotype. This analysis will be performed on mononuclear cells with a clinical flow cytometry system (panel of specific fluorophores will be used).
The primary outcome is to characterize T cell immunodeficiency in our cohort of end-stage kidney disease patients from a phenotypic and functional point of view.
Perform a non-specific assessment of T-cell activation in measuring the production of ATP ( adenosine triphosphate) and cytokines.
The primary outcome is to characterize T cell immunodeficiency in our cohort of end-stage kidney disease patients from a phenotypic and functional point of view.
Functional evaluation of T cells with specific viral assessment. Differents tests will be performed after peptidic stimulations: quantification of cytokines and proliferative capacities.
Secondary outcomes
in-vitro proof-of-concept of T-cell engineering
Development of mRNA delivery system to restore T-cell function in ESKD patients through T-cell therapy.
Sponsors and contacts
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