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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Study 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Assessment of T-cell Response and In-vitro Proof-of-concept of T-cell Engineering in Chronic End-stage Kidney Disease Patients.

Conditions

Chronic Kidney Diseases

Being tested

1 blood sample for each participant

Keywords

end-stage kidney disease, T-cells response, Immunodeficiency, Proof of concept of T-cell therapy

Medical subject headings

Renal Insufficiency, Chronic, Kidney Failure, Chronic, Immunologic Deficiency Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 1 blood sample for each participantOther

  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)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).

   Measured: 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.

   Measured: 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.

   Measured: Duration of blood collection (approximately 5 minutes in inclusion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted25 Jun 2024
2. Study start27 Nov 2024
3. Primary completionDec 2026 (estimated)
4. Study completionDec 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (7)Papers the sponsor has linked to this study.
• Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.