Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Incidence of biopsy-proven acute rejection (BPAR) at year 1 — during the first post-transplantation year
Incidence of BPAR (treated suspicious TCMR and confirmed TCMR with grade ≥ 1 and ABMR) in rATG and basiliximab groups, determined after blind central reading according to Banff 2019 classification.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| 01-TOURS | Tours | France | Recruiting |
More University Hospital, Tours trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05385432 on ClinicalTrials.gov ↗ ← All trials in France