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

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.

Timeline

Start

2023-11-07

Primary completion

2030-12-30

Completion

2030-12-30

Publications

• Results Goumard A, Sautenet B, Bailly E, Miquelestorena-Standley E, Proust B, Longuet H, Binet L, Baron C, Halimi JM, Buchler M, Gatault P. Increased risk of rejection after basiliximab induction in sensitized kidney transplant recipients without pre-existing donor-specific antibodies - a retrospective study. Transpl Int. 2019 Aug;32(8):820-830. doi: 10.1111/tri.13428. Epub 2019 Apr 12.
• Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.

Drugs

Indications