Assessment of T-cell Response and In-vitro Proof-of-concept of T-cell Engineering in Chronic ESKD Patients.
NCT ID: NCT06474169
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-11-27
2026-12-31
Brief Summary
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The study population was patients with chronic kidney disease.
Detailed Description
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ESKD is associated with a significant increase in mortality, with a death rate of 10.9% and a median age of 77 years. Thus, the average survival of patients with ESKD is lower than that of the general population. Among the causes of death in ESKD, infectious diseases represent the 2nd cause of mortality and are responsible for 15 to 20% of deaths. The occurrence of complications increases with the decline of renal function, although individual risk remains poorly characterized. Thus, after infection, ESKD patients are at increased risk of complications, hospitalization, and death. This susceptibility to infections is explained by a complex alteration of the immune system, including a pro-inflammatory state and immunodeficiency. However, this immunodeficiency is still partially understood. Premature-aged T cells were found, with a decrease in naive T cells and an increase in memory T cells, suggesting a more advanced T-cell differentiation than in the population of the same age.
The study aims to describe immunodeficiency in patients with ESKD in order to better assess the infection risk for each patient, particularly in patients awaiting kidney transplantation.
This is a comparative, prospective, non-interventional study. Three groups of participants will be included: 1) patients with ESRK, 2) patients with stage 3 CKD, and 3) healthy donors. Participants will be included after being informed and after obtaining no opposition to participate. Immunodeficiency in patients with chronic kidney disease will be performed from a single blood sample.
A total of 100 participants will be included in this study based on the detection probability of naïve T cells (45% in patients with stage 3 CKD and healthy donors vs 10-15% in ESKD patients) and considered a power of 80% and an alpha risk of 5%.
The development of blood tests to evaluate the antiviral immune response could allow for the definition of new milestones for the development of future treatments or diagnostics for these diseases.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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n°1 (ESKD)
end-stage chronic kidney disease
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)
n°2 (stage 3 CKD)
stage 3 chronic kidney disease
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)
n°3 (healthy donors)
healthy donors
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
2. Informed participants who did not object to participating in the study
Exclusion Criteria
2. Prior organ transplantation (including bone marrow transplantation)
3. Previous treatment with immunosuppressive agents (such as Rituximab, Eculizumab, Tacrolimus or Ciclosporin, Cellcept or Imurel) within 2 years prior to inclusion
4. Participant under guardianship, curatorship or deprived of liberty
5. Pregnant or breastfeeding women
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
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Locations
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Center Hospitalier Universitaire d'Orléans
Orléans, , France
Countries
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Central Contacts
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Facility Contacts
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Manon DEKEYSER, PhD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CHRO-2023-11
Identifier Type: -
Identifier Source: org_study_id