The Impact of Early Protocol Biopsy in Kidney Transplant
Status:
Unknown status
Trial end date:
2019-04-01
Target enrollment:
Participant gender:
Summary
- The purpose of this study is evaluating the impact of steroid pulse therapy (SPT) on SCR
revealed on PB in KT recipients maintained on TAC/MMF and corticosteroid.
- In our institution, since routine protocol biopsies are performed at 2 weeks, 1 year,
and 2 years after renal transplantation, it is practically difficult that graft survival
is used as an endpoint for randomized controlled trials.
- From a meta-analysis for 31 observational studies , acute rejection was associated with
an increased risk of graft loss risk ratios ranged from 1.2 - 10.5. Furthermore, chronic
allograft nephropathy and graft survival is strongly correlated with acute rejection
episode during the first year after renal transplantation.
- Therefore, the aim of this study is to investigate the effect of early steroid pulse
therapy for the reduction of acute rejection episode during the first year after KT in
the patients who will show subclinical changes at 2-week protocol biopsy.
- The histological feature at 1 year PB, graft function (represented by serum creatinine
level and eGFR) during the 1st year of KT were compared between SCR group and non-SCR
group.
- Additional benefits including early detection of polioma BK virus associated nephritis
(BKVAN) and relapsed underlying disease are also evaluated.