The purpose of this study is to determine whether bortezomib is effective in the treatment of acute cellular rejection after kidney transplantation.
When acute cellular rejection occurred in kidney allograft, investigators administer high dose steroid. However, there is insufficient effect in about 20-30%. Bortezomib acts not only on plasma cells, but also T cells, B cells and dendritic cells. In addition, bortezomib is relatively safe drug compared to thymoglobulin which investigators use in the cases of steroid failure. Therefore, investigators administer bortezomib with steroid in one group, and compared the group with the other group in which conventional steroid treatment is done.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
In one group, investigators administer bortezomib and steroid to manage acute cellular rejection in kidney transplantation, and compare the results with another group in which only steroid was administered.
Investigators administer steroid in both groups for conventional treatment of acute cellular rejection.
Asan Medical Center
Seoul, South Korea
RECRUITINGSerum creatinine
Investigators measure patients' serum creatinine at day 14.
Time frame: Day 14
Incidence of steroid failure
Steroid failure is defined as serum creatinine at day 8 ≥ serum creatinine at day 0.
Time frame: Day 7
Serum creatinine
Investigators measure patients' serum creatinine at month 1.
Time frame: Month 1
Infection
Infection as measured by clinical, laboratory and microbiological data
Time frame: Until 1 year after intervention
Recurrence of Rejection
Recurrence of rejection as measured by clinical and laboratory data with graft biopsy.
Time frame: Until 1 year after intervention
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