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NOT YET RECRUITING
NCT05385432
PHASE3

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

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

Basiliximab

Simulect® IV 40mg D0 and D4