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

Recruiting now · Phase 3

Conditions studied: Renal Transplant Rejection, Induction Therapy

In brief

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.

Key facts

Study ID

NCT05385432

Run by

University Hospital, Tours

People needed

244

Starts

2023-11-07

Expected to finish

2030-12-30

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%
• Ability for participant to comply with the requirements of the study
• Written informed consent obtained from the participant
• Participants covered by or entitled to social security.

You may not qualify if…

• 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)
• Incompatible ABO transplantation
• Leukopenia lower than 3000/mm3
• Thrombocytopenia (platelets < 50G/L)
• Donor EBV Positive / Recipient EBV Negative
• Active HIV infection (positive viral charge)
• History of solid cancer (< 5 years), except to skin carcinoma (squamous-cell and basal-cell carcinoma).History of some solid cancer (prostate, breast) can be reduced (<2 years), depending on the prognosis for cancer recurrence as assessed by the oncologist.
• History of lymphoma
• Patients with severe uncontrolled systemic infection or severe allergy requiring acute or chronic treatment; Aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT) or bilirubin greater than 3 times normal
• Known hypersensitivity or contra-indication to rabbit proteins, basiliximab including the product excipients
• Contra-indication to tacrolimus,mycophenolic acid ans steroids
• Pregnant or breastfeeding woman, or woman of childbearing potential not using a highly effective method of contraception, or having a desire to conceive, during the whole trial duration. A β-HCG test will be performed for inclusion.
• Patient under judicial protection, deprivation of liberty
• Participation in other interventional research with an investigational drug or medical device.

Where it is running

• 01-TOURS — Tours, France (enrolling)

Full record on ClinicalTrials.gov

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