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

Launched by UNIVERSITY HOSPITAL, TOURS · May 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two different types of medications used during kidney transplant induction therapy for patients who have been sensitized but do not have specific antibodies against their donor. The trial aims to compare basiliximab and rabbit anti-thymocyte globulin (rATG) to see which may work better in preventing kidney transplant rejection in these patients. Induction therapy is an important part of the transplant process because it helps reduce the risk of the body rejecting the new kidney.

To participate in this study, patients must be between the ages of 18 and 79 and must be on the waiting list for a kidney transplant. They should also have been identified with at least one type of antibody related to their immune system but not have specific antibodies that could complicate the transplant. Participants will need to provide written consent and show they can follow the study requirements. This trial is currently not yet recruiting, but if chosen, participants can expect to receive one of the medications and will be monitored closely for their health and kidney function throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.