INduction in Sensitized kidney Transplant recipients without pre-Existing donor-specific AntiboDies: a randomized multicentre trial between a lymphocyte depleting and basiliximab (INSTEAD)

Centre Hospitalier Regional Universitaire De Tours0 个研究点目标入组 244 人开始时间: 2023年3月29日最近更新: 2024年7月22日

适应症

试验速览

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•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 understand the nature and objectives of the study; to comply with the requirements of the study, Written informed consent obtained from the participant, Participants covered by or entitled to social security

•DSA (positive virtual crossmatch with MFI threshold at 1000), 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 Thymoglobulin® (rATG) or Simulect® (basiliximab) including the product excipients, Contra-indication to tacrolimus, mycophenolic acid and steroids, 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 transplantation, Patient under judicial protection, deprivation of liberty, Participation in another interventional research with an investigational drug or medical device, Combined transplantation, 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 (< 2 years), except to skin carcinoma (squamous-cell and basal-cell carcinoma)

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