Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-79
SponsorUniversity Hospital, Tours
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 18-79
Registered on the transplant waiting list
At least one anti-HLA antibody identified by the Luminex Single Antigen test with MFI ≥ 2000 (MFI threshold in agreement with French kidney allocation system.)
Graft incompatibility rate (TGI) < 85%
Disqualifiers
DSA (negative virtual crossmatch with MFI threshold at 1000)
Combined transplantation
Usual contraindications to a kidney transplantation such as morbid obesity (BMI > 40 kg/m2), active drug abuse, uncontrolled psychiatric disease, or decompensated heart failure
Beneficiaries of kidney transplants from donations after uncontrolled circulatory death (Maastricht II)
Trial design
Design model
Parallel
Treatments tested in this trial
Rabbit Anti thymocyte globulin (rATG)
DrugThe 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
DrugSimulect® IV 40mg D0 and D4
Treatment groups
244 Participants
are divided into 2 treatment groupsGroup A: rabbit antithymocyte globulin (rATG)Experimental treatment 1 intervention
Group B: BasiliximabActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of biopsy-proven acute rejection (BPAR) at year 1
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.
Time frame
during the first post-transplantation yearSecondary outcomes
1
Incidence of BPAR in rATG and basiliximab groups at year 3.
Incidence of BPAR (suspicious and confirmed TCMR with grade ≥ 1 and ABMR) in rATG and basiliximab groups at year 3.
Time frame
at year 32
Incidence of composite criteria
Incidence of composite criteria including BPAR (suspicious and confirmed TCMR with grade ≥ 1 and ABMR), death and graft loss (retransplantation or dialysis) at year 3.
Time frame
at year 33
Incidence of confirmed TCMR and ABMR in rATG and basiliximab groups at year 1 and 3.
Incidence of confirmed TCMR and ABMR in rATG and basiliximab groups at year 1 and 3.
Time frame
at year 1 and 34
Incidence of de novo DSA in rATG and basiliximab groups at year 1 and 3
Incidence of de novo DSA in rATG and basiliximab groups at year 1 and 3
Time frame
at year 1 and 3Sponsors and contacts
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Source ClinicalTrials.gov