An observational study in Chronic Kidney Diseases, sponsored by Centre Hospitalier Régional d'Orléans. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Centre Hospitalier Régional d'Orléans · Observational
Among 145 studies in Kidney Failure, Chronic with a site in France — 28 open to participants now, 33 under way, 6 of them phase 3. Kidney Failure, Chronic · France.
Among the 145 studies in Kidney Failure, Chronic with a site in France, this one is the 27th largest by planned enrollment of the 40 observational ones that give a count, is one of 10 that started in 2024, is one of 40 observational ones, reaches primary completion later than 12 of the 32 other live ones, and was the 137th registered.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
Browse Kidney Failure, Chronic studies →28 of the 145 studies in Kidney Failure, Chronic with a site in France are open now. Recruiting first, the newest first:
Central Hospital, Nancy, France · Sites in France
University of Avignon · Sites in France
University Hospital, Strasbourg, France · Sites in France
Hospices Civils de Lyon · Sites in France
Assistance Publique Hopitaux De Marseille · Sites in France
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 170 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
145 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 16 · Phase 3 26 · Phase 4 9
First in 1994; this study’s year is marked. 10 started in 2024.
This study's planned enrollment of 100 is below the median of 120 across 442 observational studies indexed under Kidney Failure, Chronic.
Median enrollment 70 across the 105 interventional studies, 177 across the 40 observational. Of the 90 that completed or were terminated, 15 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
39 of 145 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Régional d'Orléans is the lead sponsor of 132 studies on the registry; 32 are open to participants now.
Centre Hospitalier Régional d'Orléans has 1 study filed under Kidney Failure, Chronic — fewer than ten, so there is no comparison to draw.
8 of the studies in Kidney Failure, Chronic with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05562869Phase 3Nantes University HospitalBelatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction | 2027-05-03 |
| NCT06692231Centre Hospitalier de VichyImpact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients | 2026-11-30 |
| NCT06474169Centre Hospitalier Régional d'OrléansAssessment of T-cell Response and In-vitro Proof-of-concept of T-cell Engineering in Chronic ESKD Patients. | 2026-12 |
| NCT06595680Hospices Civils de LyonDevelopment of an Innovative Hemodialysis Method to Improve Dialytic Clearance of Protein-bound Uremic Toxins | 2027-01-22 |
| NCT06887075University Hospital, BordeauxSystemic Activation of Inflammasomes and Frailty in Older Candidates to Kidney Transplantation | 2027-02-15 |
Among the 145 studies in Kidney Failure, Chronic with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 442 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Centre Hospitalier Régional d'Orléans is the lead sponsor of 132 studies on the registry; 32 are open to participants now.
Compared within Kidney Failure, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Renal Insufficiency, Chronic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
end-stage chronic kidney disease
Other: 1 blood sample for each participant
stage 3 chronic kidney disease
Other: 1 blood sample for each participant
healthy donors
Other: 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)
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)
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)
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)
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)
Plan to share: No
Started Nov 2024 (actual). Primary completion is estimated for Dec 2026, 25 months after the start.
Of 131 non-industry observational studies under Kidney Failure, Chronic, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 62. This study's planned 25 months is below that.
Counting every sponsor, half of 150 studies reached it within 29 months; a quarter within 11 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
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Centre Hospitalier Régional d'Orléans →