Immune Response in Desensitized Patients (NCT05785936) | Clinical Trial Compass
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Immune Response in Desensitized Patients
20 participantsStarted 2023-05-01
Plain-language summary
Kidney transplantation is the best treatment for chronic renal failure in terms of morbidity and mortality, quality of life for patients and health economics. Sensitization with anti-Human Leukocyte Antigen antibodies is a barrier to access to transplantation.
Highly-sensitized patients wait 2 to 3 times longer on the waiting list with important health and economic consequences. Desensitization strategies by apheresis techniques allow access to a transplant with a negative crossmatch (absence of specific HLA antibodies against their donor) on the day of the transplant.
The main objective of this study is to assess the impact of desensitization on the antibody memory immune response in highly sensitized patients awaiting kidney transplantation.
The analyses will be based on samples from the 20 patients (10 desensitized transplanted patients, 5 highly sensitized non-desensitized transplanted patients and 5 healthy donors) at the University Hospital of Grenoble, France.
Analyses will include phenotypic and immuno-metabolic analysis by flow cytometry of antibody-secreting cells, a functional analysis by anti HLA ELISpot B technique and histological analysis of post-kidney transplantation follow-up renal biopsies with gene expression mapping (RNA tissue labeling using the Nanostring technique) within the renal parenchyma.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients (age \>18 years) with end-stage renal disease (on hemodialysis or peritoneal dialysis or stage V chronic kidney disease) who are candidates for pre-renal transplantation desensitization from living or deceased donors.
* For women of childbearing age: a plasma pregnancy test before inclusion is mandatory. Highly effective contraception for women of childbearing age is required throughout the study period:
* combined hormonal contraception (containing estrogen and progestin)
* contraception associated with ovulation inhibition :
* oral
* intravaginal
* transdermal
* Progestin-only hormonal contraception associated with ovulation inhibition:
* oral
* injectable
* implantable
* intrauterine device (IUD) - intrauterine hormone delivery system (IUS)
* bilateral tubal occlusion
* vasectomized partner
* sexual abstinence
* Have signed the DELIGHT protocol consent.
* Affiliated to a social security system
* Can be contacted in case of emergency
* For the control groups :
* Healthy controls from blood samples (centrifugation ring) from the French Blood Agency. The use of healthy controls is necessary to compare immunological analyses to a reference group without immunosuppression.
* Highly sensitized kidney transplant patients without the need for de-immunization. Hyperimmunization is defined by a Panel Reactive Antibody score \> 85%. Transplantation can be from deceased or living donors.
Exclusion Criteria:
* Patients who object to…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Change in Flow Cytometry analyses of Peripheral Blood Mononuclear Cells
Timeframe: Before desensitization, at the time of transplantation and Before desensitization, at the time of transplantation and post transplantation
2
Change in Anti HLA B-cell ELISpot response
Timeframe: Before desensitization, at the time of transplantation and Month 3, Month 6 and Month 12 post transplantation
3
Change in Flow Cytometry analyses of medullary cells
Timeframe: The first day of desensitization and at the day of kidney transplantation
4
Change in analyses of RNA expression on renal histology
Timeframe: Month1, Month 3 and Month 12 post transplantation