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

• Status: Not yet recruiting
• Trial end date: 2027-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Tours
• Treatments: Antilymphocyte Serum; Basiliximab; Immunosuppressive Agents; Mycophenolic Acid; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• Patients aged between 18-79

• At least one anti-HLA antibody identified by the Luminex Single Antigen test with MFI ≥ 2000

• 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

Exclusion Criteria:

• DSA (positive virtual crossmatch with MFI threshold at 500)

• Patient under legal protection, under guardianship or curatorship

• Combined transplantation

• Beneficiaries of kidney transplants from donations after uncontrolled circulatory death (Maastricht II)

• Incompatible ABO transplantation

• Leukopenia lower than 3000/mm3

• Donor EBV positive / recipient EBV Negative

• History of solid cancer (< 2 years), except to skin carcinoma (squamous-cell and basal-cell carcinoma)

• 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, tacrolimus, mycophenolic acid, or any of the product excipients.

• Pregnant or breastfeeding woman, or woman of childbearing potential not using an effective method of contraception, or having a desire to conceive within 12 months of randomization

• Concurrent participation in any interventional clinical trial conducted by the recipient