A phase- I clinical trial to determine safety and feasibilty of intravenous administration of mitomycin C-treated donor peripheral blood mononuclear cells in patients with chronic kidney disease stage KDIGO 4 or 5 (i.e. GFR 15-30 mL/min or \< 15 mL/min) who receive a kidney transplant from a living donor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
14
MICs are given intravenously 2 or 7 days before kidney transplantation from a living donor
University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
The primary outcome measure is the frequency of adverse events after intravenous administration of MICs within 30 days after transplantation.
Time frame: 30 days
Cumulative incidence of infection
Time frame: 30 days
Cumulative incidence of CMV reactivation
Time frame: 30 days
Number of patients with PTLD
Time frame: 30 days
Number of patients with delayed graft function
Time frame: 7 days
Number of patients with a pos. CDC and/or ELISA crossmatch
Time frame: day -1 before transplantation
Number of patients with DSA
Time frame: day -1 before transplantation and day 7 and 30 after transplantation
Incidence of biopsy-proven cellular rejection
Time frame: 30 days
Incidence of biopsy-proven antibody-mediated rejection
Time frame: 30 days
Number of patients with stable graft function (S-creatinine < 2mg/dL)
Time frame: 30 days
Patient and graft survival
Time frame: 30 days
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