Kidney Transplantation
Conditions
Brief summary
The purpose of this study is to determine whether bortezomib is effective in the treatment of acute cellular rejection after kidney transplantation.
Detailed description
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.
Interventions
DRUGBortezomib
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.
DRUGSteroid
Investigators administer steroid in both groups for conventional treatment of acute cellular rejection.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* living donor kidney transplantation recipients * patients who were performed kidney biopsies because of laboratory and clinically suspected rejection * Biopsy proven acute cellular rejection (Banff I - IIA) with C4d negative * Single luminex panel reactive antibody (PRA) I & II mean fluorescent intensity (MFI) \< 3000
Exclusion criteria
* patients who received other major organ transplantation * combined with urinary tract infection or obstruction * combined with acute antibody mediated rejection * poor compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine | Day 14 | Investigators measure patients' serum creatinine at day 14. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of steroid failure | Day 7 | Steroid failure is defined as serum creatinine at day 8 ≥ serum creatinine at day 0. |
| Serum creatinine | Month 1 | Investigators measure patients' serum creatinine at month 1. |
| Infection | Until 1 year after intervention | Infection as measured by clinical, laboratory and microbiological data |
| Recurrence of Rejection | Until 1 year after intervention | Recurrence of rejection as measured by clinical and laboratory data with graft biopsy. |
Countries
South Korea
Contacts
Primary ContactSu-Kil Park, M.D., PhD
Backup ContactChung Hee Baek, M.D.
Outcome results
None listed