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
Qualifiers
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
Treatments tested in this trial
- Rabbit Anti thymocyte globulin (rATG)
- Basiliximab
Treatment groups
244 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov