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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional d'Orléans

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 1 blood sample for each participant

    Other intervention

    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)

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: n°1 (ESKD)1 intervention
Group B: n°2 (stage 3 CKD)1 intervention
Group C: n°3 (healthy donors)1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Duration of blood collection (approximately 5 minutes in inclusion)
2

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.

Time frame
Duration of blood collection (approximately 5 minutes in inclusion)
3

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.

Time frame
Duration of blood collection (approximately 5 minutes in inclusion)

Secondary outcomes

1

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.

Time frame
For each outcome, duration of blood collection (approximately 5 minutes in inclusion)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.