Assessment of T-cell Response and In-vitro Proof-of-concept of T-cell Engineering in Chronic ESKD Patients.

Condition(s) studied

Investigational drug(s) / intervention(s)

1 blood sample for each participant: Blood 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)

Study summary

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

Primary outcome measure(s)

• 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. — Duration of blood collection (approximately 5 minutes in inclusion)
  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. — Duration of blood collection (approximately 5 minutes in inclusion)
  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. — Duration of blood collection (approximately 5 minutes in inclusion)
  Functional evaluation of T cells with specific viral assessment. Differents tests will be performed after peptidic stimulations: quantification of cytokines and proliferative capacities.

Trial sites (1)

More Centre Hospitalier Régional d'Orléans trials in France

Other trials for the same condition