The objective of this trial is to determine if clonal deletion before kidney transplantation can effectively reduce the need for post transplant immunosuppression. The investigators will adapt a DAWN (Drugs (immunosuppressants) Added When Needed) treatment protocol to assess the effect of clonal deletion and closely monitor acute rejection, renal function, and graft survival. 15 patients eligible for the study as described below will be enrolled.
The objective of this trial is to determine if clonal deletion can effectively reduce the need for post transplant immunosuppressive medicine. Emphasis will be placed on adverse events that are associated with clonal deletion. The investigators will assess whether DAWN (Drugs (immunosuppressants) Added When Needed) is feasible in living-relative donor kidney transplantation and the effectiveness of clonal deletion treatment on the rate of rejection, patient survival, and graft function from day 0 to 12 months after transplantation. Numbers of patients on single drug and dual therapy immunosuppression will be counted. Additionally, the investigators would assess time to immune event (rejection or antibody), the severity of acute rejection or antibody mediated rejection by Banff criteria, the incidence of delayed graft function (defined as the need for post-transplant dialysis), and the incidence of adverse events including infection, grade 3 and above non-hematologic toxicities, and grade 4 hematologic toxicities.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
before transplantation,200mL of donor whole blood will be transfused to the recipient
MMF and Bortezomib will be administered after donor specific transfusion
drugs (corticosteroid, MMF and/or CNI) will be added according to the recipients immuno event and donor specific antibody
No. 156, Xi er huan Road
Fuzhou, Fujian, China
RECRUITINGDosage of immunosuppressants
Effectiveness of clonal deletion on reducing the dosage of immunosuppressants (calcineurin inhibitor plus mycophenolate, azothioprine, or sirolimus).
Time frame: one year
immune event
Time to immune event (acute rejection or DSA);
Time frame: 1 year
DSA
Proportion of patients who become positive for donor specific HLA antibodies post transplant
Time frame: 1 year
DGF
Incidence of delayed graft function (defined as need for post-transplant dialysis)
Time frame: 1 years
Renal function
Change in renal function as determined by estimated glomerular filtration rate and proteinuria (\>1g) at 1 year post transplant
Time frame: 1 year
Survival
Allograft Survival at 1 year post transplant
Time frame: 1 year
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