Delayed Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-matched Kidney… (NCT05525507) | Clinical Trial Compass
RecruitingPhase 1
Delayed Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-matched Kidney Transplants
United States10 participantsStarted 2022-12-21
Plain-language summary
The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females ages 18 years and older with a pre- existing kidney transplant from an HLA-matched living donor.
✓. Pre-existing living kidney transplant must be within 3 months to 5 years from date of scheduled HPSC infusion.
✓. No history of rejection with current HLA matched kidney transplant.
✓. Recipient is without post-transplant major complications, including de novo malignancy, active infection or rejection.
✓. Stable renal function determined per investigator discretion.
✓. Agreement to participate in the study and ability to give informed consent.
✓. Meets institutional criteria for HSPC infusion.
✓. Resides or is willing to stay within 3 hours distance from UCLA Medical Center by ground transportation for the first three to six months of the trial at the physician's discretion.
Exclusion criteria
✕. Donor is identical twin.
✕. Major ABO incompatibility with donor
✕. Positive HLA Donor-Specific Antibody (DSA)
✕. History of multi-organ transplantation
✕. History of rejection with current HLA-matched kidney transplant
What they're measuring
1
Incidence of successful discontinuation of immunosuppression
✕. History of post-transplant major complications, including de novo malignancy, active/chronic infection or rejection, with the exception of low risk, early-stage malignancy with
✕. History of active malignancy within the past 5 years with the exception: