Assessment of T-cell Response and In-vitro Proof-of-concept of T-cell Engineering in Chronic ESKD… (NCT06474169) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of T-cell Response and In-vitro Proof-of-concept of T-cell Engineering in Chronic ESKD Patients.
France100 participantsStarted 2024-11-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female ≥ 18 years
. Informed participants who did not object to participating in the study
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to be focused on studying the immune system in people with end-stage kidney disease rather than testing a new treatment — can you help me understand what that would actually mean for me personally, and whether I'd receive any direct medical benefit from participating?
2Since this is listed as a research or characterization study with no assigned phase, what exactly would be done to my blood or immune cells, and are there any risks involved in the sample collection process?
3The trial is looking at T-cell deficiencies in people with chronic kidney disease — based on my current immune health and kidney status, does my doctor think my situation matches what this study is trying to learn about?
4The study mentions 'in-vitro proof-of-concept of T-cell engineering' — can my doctor explain what that means in plain terms, and whether any of my cells would be modified or used in experiments outside my body?
5Given that this is still in a research and characterization phase rather than a treatment trial, should I be looking at other options — like standard treatments or different clinical trials — alongside or instead of this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: 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.
Timeframe: 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.
Timeframe: Duration of blood collection (approximately 5 minutes in inclusion)