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Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies

Induction in Sensitized Kidney Transplant Recipients Without Preexisting Donor-specific antiboDies: a Randomized Multicentre Trial Between a Lymphocyte Depleting and Basiliximab.

Nábor prebieha  •  Fáza 3  •  intervenčná  •  NCT05385432

Stručný súhrn

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.

Základné údaje

Základné údaje o štúdii
OchoreniaRenal Transplant Rejection, Induction Therapy
Intervencie DRUG: Rabbit Anti thymocyte globulin (rATG)
DRUG: Basiliximab
SponzorUniversity Hospital, Tours
Plánovaný počet244
Začiatok2023-11-07
Predp. ukončenie (primárne)2030-12-30
KrajinyFrance
Posledná aktualizácia2026-06-18
Upozornenie: údaje sú orientačné a podliehajú zmenám. Úplné vstupné/vylučovacie kritériá, kontakty a aktuálny stav nájdete v oficiálnom registri. Tento prehľad nenahrádza lekársku konzultáciu.