Clinical Trial

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

Study acronym: INSTEAD
Recruiting Phase 3
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-05-17; most recent amendment 2026-06-16.
Status change: Not Yet Recruiting → Recruiting 2026-06-16
Trial Details
NCT Number NCT05385432
Lead Sponsor University Hospital, Tours
Conditions Renal Transplant Rejection, Induction Therapy
Enrollment 244 participants
Start Date 2023-11-07
Primary Completion 2030-12-30 (estimated)
Study Completion 2030-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-18