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

NCT06474169 | Recruiting

• 1 other identifier: CHRO-2023-11
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases

Keywords

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

Outcome Measures

Primary Outcomes (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.

  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).

  Duration of blood collection (approximately 5 minutes in inclusion)

• 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.

  Duration of blood collection (approximately 5 minutes in inclusion)

• 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.

  Duration of blood collection (approximately 5 minutes in inclusion)

Secondary Outcomes (1)

• in-vitro proof-of-concept of T-cell engineering

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

Study Arms (3)

n°1 (ESKD)

end-stage chronic kidney disease

Other: 1 blood sample for each participant

n°2 (stage 3 CKD)

stage 3 chronic kidney disease

Other: 1 blood sample for each participant

n°3 (healthy donors)

healthy donors

Other: 1 blood sample for each participant

Interventions

1 blood sample for each participant OTHER

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)

n°1 (ESKD); n°2 (stage 3 CKD); n°3 (healthy donors)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Male or female ≥ 18 years
• Informed participants who did not object to participating in the study

You may not qualify if:

• Chronic progressive infections
• Prior organ transplantation (including bone marrow transplantation)
• Participant under guardianship, curatorship or deprived of liberty
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Center Hospitalier Universitaire d'Orléans

Orléans, 45067, France

RECRUITING

Related Publications (7)

• Ishigami J, Matsushita K. Clinical epidemiology of infectious disease among patients with chronic kidney disease. Clin Exp Nephrol. 2019 Apr;23(4):437-447. doi: 10.1007/s10157-018-1641-8. Epub 2018 Sep 3.

  PMID: 30178234 BACKGROUND

• Syed-Ahmed M, Narayanan M. Immune Dysfunction and Risk of Infection in Chronic Kidney Disease. Adv Chronic Kidney Dis. 2019 Jan;26(1):8-15. doi: 10.1053/j.ackd.2019.01.004.

  PMID: 30876622 BACKGROUND

• Betjes MG. Immune cell dysfunction and inflammation in end-stage renal disease. Nat Rev Nephrol. 2013 May;9(5):255-65. doi: 10.1038/nrneph.2013.44. Epub 2013 Mar 19.

  PMID: 23507826 BACKGROUND

• Betjes MG, Huisman M, Weimar W, Litjens NH. Expansion of cytolytic CD4+CD28- T cells in end-stage renal disease. Kidney Int. 2008 Sep;74(6):760-7. doi: 10.1038/ki.2008.301. Epub 2008 Jul 9.

  PMID: 18615000 BACKGROUND

• Betjes MG, Langerak AW, van der Spek A, de Wit EA, Litjens NH. Premature aging of circulating T cells in patients with end-stage renal disease. Kidney Int. 2011 Jul;80(2):208-17. doi: 10.1038/ki.2011.110. Epub 2011 Apr 27.

  PMID: 21525849 BACKGROUND

• Litjens NH, van Druningen CJ, Betjes MG. Progressive loss of renal function is associated with activation and depletion of naive T lymphocytes. Clin Immunol. 2006 Jan;118(1):83-91. doi: 10.1016/j.clim.2005.09.007. Epub 2005 Oct 27.

  PMID: 16257266 BACKGROUND

• Xiang F, Chen R, Cao X, Shen B, Chen X, Ding X, Zou J. Premature aging of circulating T cells predicts all-cause mortality in hemodialysis patients. BMC Nephrol. 2020 Jul 13;21(1):271. doi: 10.1186/s12882-020-01920-8.

  PMID: 32660510 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

For this study, the collection of blood samples is storage with specific samples : * Peripheral blood mononuclear cell (PBMC) * Serum * Plasma

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Central Study Contacts

Manon DEKEYSER, PhD

CONTACT

+33238229870; manon.dekeyser@chu-orleans.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 25, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)