Chronic Kidney DiseasesLYMPHOVIR-IRCTNCT06474169
Assessment of T-cell Response and In-vitro Proof-of-concept of T-cell Engineering in Chronic ESKD Patients.
An observational study of Chronic Kidney Diseases, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- 1 blood sample for each participant
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Male or female ≥ 18 years
- Informed participants who did not object to participating in the study
Who cannot join
- 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
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Center Hospitalier Universitaire d'Orléans
Orléans, 45067
Manon DEKEYSER, PhD, 2 38 22 98 29 ext. +33, manon.dekeyser@chu-orleans.fr
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.
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.
Read the detailed description
The development of chronic kidney disease (CKD) and its progression to this terminal stage (end-stage kidney disease, ESKD) remains a significant source of reduced quality of life and premature mortality. ESKD represents the complete and definitive alteration of renal function requiring the use of renal replacement therapy (dialysis or kidney transplantation).
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
- 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)
| Study group | Role | What they receive |
|---|---|---|
| n°1 (ESKD) | end-stage chronic kidney disease Receives: Other: 1 blood sample for each participant | |
| n°2 (stage 3 CKD) | stage 3 chronic kidney disease Receives: Other: 1 blood sample for each participant | |
| n°3 (healthy donors) | healthy donors Receives: Other: 1 blood sample for each participant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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.
Measured: For each outcome, 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.
- First posted25 Jun 2024
- Study start27 Nov 2024
- Primary completionDec 2026 (estimated)
- 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.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474169
- Sponsor's protocol ID
- CHRO-2023-11
- Acronym
- LYMPHOVIR-IRCT
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30178234Syed-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.
PubMed 30876622Betjes 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.
PubMed 23507826Betjes 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.
PubMed 18615000Betjes 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.
PubMed 21525849Litjens 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.
PubMed 16257266Xiang 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.
PubMed 32660510
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of T-cell Response and In-vitro Proof-of-concept of T-cell Engineering in Chronic End-stage Kidney Disease Patients.
- ClinicalTrials.gov ID
- NCT06474169
- Acronym / sponsor ID
- LYMPHOVIR-IRCT / CHRO-2023-11
- Conditions
- Chronic Kidney Diseases
- Keywords
- end-stage kidney disease, T-cells response, Immunodeficiency, Proof of concept of T-cell therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The development of chronic kidney disease (CKD) and its progression to this terminal stage (end-stage kidney disease, ESKD) remains a significant source of reduced quality of life and premature mortality. ESKD represents the complete and definitive alteration of renal function requiring the use of renal replacement therapy (dialysis or kidney transplantation).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| n°1 (ESKD) | – | Other: 1 blood sample for each participantend-stage chronic kidney disease |
| n°2 (stage 3 CKD) | – | Other: 1 blood sample for each participantstage 3 chronic kidney disease |
| n°3 (healthy donors) | – | Other: 1 blood sample for each participanthealthy donors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- Male or female ≥ 18 years
- Informed participants who did not object to participating in the study
Key exclusion criteria (5 listed)
- 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
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 blood sample for each participantBlood 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) | Other | n°1 (ESKD), n°2 (stage 3 CKD), n°3 (healthy donors) |
Primary outcome
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
1 secondary outcome
in-vitro proof-of-concept of T-cell engineering
Time frame: For each outcome, duration of blood collection (approximately 5 minutes in inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 30178234Ishigami 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.
- Background: PubMed 30876622Syed-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.
- Background: PubMed 23507826Betjes 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.
- Background: PubMed 18615000Betjes 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.
- Background: PubMed 21525849Betjes 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.
- Background: PubMed 16257266Litjens 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.
- Background: PubMed 32660510Xiang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon DEKEYSER, PhD (+33238229870, manon.dekeyser@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Duration of blood collection (approximately 5 minutes in inclusion)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06474169, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.