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Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies
Sponsor: University Hospital, Tours
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.
Official title: Induction in Sensitized Kidney Transplant Recipients Without Preexisting Donor-specific antiboDies: a Randomized Multicentre Trial Between a Lymphocyte Depleting and Basiliximab.
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
244
Start Date
2023-09-12
Completion Date
2030-03-01
Last Updated
2023-09-05
Healthy Volunteers
No
Interventions
Rabbit Anti thymocyte globulin (rATG)
The infusion of rTAG (Thymoglobulin® (1.5mg/kg/day, maximum daily dose: 100 mg)) starts just after the randomization pre-operatively on a functional arteriovenous fistula or a high-flow venous catheter during 3 to 7 days until efficient tacrolimus level is obtained.
Basiliximab
Simulect® IV 40mg D0 and D4