Purpose: Subclinical rejection (SCR) has been correlated with subsequent chronic allograft nephropathy and allograft dysfunction. Steroid pulse therapy (SPT) has been found to be effective for SCR. However, controversy remains about borderline change. The purpose of this study is to investigate the effect of early SPT on reduction of acute rejection episodes during the first year after kidney transplantation in recipients who exhibit subclinical borderline changes (SCBC) at the 2-week protocol biopsy.
Methods: This study was a randomized clinical study in which 17 recipients with stable kidney graft function and borderline changes in the 2-week protocol biopsies were enrolled. The recipients were divided into two groups depending on SPT. The treatment (Tx) group included 9 recipients who were treated with SPT, while the nontreatment (NTx) group included 8 untreated recipients. We investigated changes in Banff scores through protocol biopsy, graft function and infection rate after 1year.
Results: The numbers of recipients who underwent acute cellular rejection and borderline change within 1 year were 5 (55.6%) in the Tx group and 4 (50.0%) in the NTx group, with no difference between the two groups (P > 0.999). There also was no difference between the two groups in the change of Banff score between the 2-week and 1-year protocol biopsies. In addition, there was no difference in the rates of opportunistic infections including cytomegalovirus (P = 0.471) and BK polyomavirus (P > 0.999). Also, there was no difference between the two groups with respect to creatinine and eGFR at 2-weeks to 3-years post-surgery.
Conclusion: There was no difference in Banff score change, graft function, and infection rate between the two groups. In conclusion, we suggest that SPT is not essential in SCBC.