Status:
NOT_YET_RECRUITING
Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies
Lead Sponsor:
University Hospital, Tours
Conditions:
Renal Transplant Rejection
Induction Therapy
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief 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 recep...
Detailed Description
Kidney transplantation is the first-line treatment of end stage renal disease, improving life expectancy and quality of life in comparison to dialysis. The success of transplantation is a consequence ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT05385432
Start Date
September 12 2023
End Date
March 1 2030
Last Update
September 5 2023
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