Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies (NCT05385432) | Clinical Trial Compass
RecruitingPhase 3
Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies
France244 participantsStarted 2023-11-07
Plain-language summary
Induction therapy decreases the rate of acute allograft rejection in kidney transplant recipients (KTRs) and is strongly recommended. Polyclonal lymphocyte-depleting antibodies and interleukin-2 receptor (IL2R) antagonists are therefore widely used around the world, with a leading position for rabbit anti-thymocyte globulin (rATG, Thymoglobulin®) and basiliximab (Simulect®), respectively. The actual immunological risk of the sensitized KTRs without donor specific antibodies (DSAs) is still debated. The benefit-risk equation of lymphocyte depleting antibodies (versus IL2R antagonists) is not known in sensitized KTRs without DSAs. This clinical trial will compare the efficacy and safety of basiliximab and rATG in sensitized KTR without pre-existing DSAs detected by Luminex.
Who can participate
Age range
18 Years – 79 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:
* Patients aged between 18-79
* Registered on the transplant waiting list
* At least one anti-HLA antibody identified by the Luminex Single Antigen test with MFI ≥ 2000 (MFI threshold in agreement with French kidney allocation system.)
* Graft incompatibility rate (TGI) \< 85%
* Ability for participant to comply with the requirements of the study
* Written informed consent obtained from the participant
* Participants covered by or entitled to social security.
Exclusion Criteria:
* DSA (negative virtual crossmatch with MFI threshold at 1000)
* Combined transplantation
* Usual contraindications to a kidney transplantation such as morbid obesity (BMI \> 40 kg/m2), active drug abuse, uncontrolled psychiatric disease, or decompensated heart failure
* Beneficiaries of kidney transplants from donations after uncontrolled circulatory death (Maastricht II)
* Incompatible ABO transplantation
* Leukopenia lower than 3000/mm3
* Thrombocytopenia (platelets \< 50G/L)
* Donor EBV Positive / Recipient EBV Negative
* Active HIV infection (positive viral charge)
* History of solid cancer (\< 5 years), except to skin carcinoma (squamous-cell and basal-cell carcinoma).History of some solid cancer (prostate, breast) can be reduced (\<2 years), depending on the prognosis for cancer recurrence as assessed by the oncologist.
* History of lymphoma
* Patients with severe uncontrolled systemic infection or severe allergy requiring acute or chronic treatment; Aspartate aminotransf…
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
Incidence of biopsy-proven acute rejection (BPAR) at year 1
Timeframe: during the first post-transplantation year