The Impact of Early Protocol Biopsy in Kidney Transplant
The Impact of Early Protocol Biopsy in Kidney Transplant
-  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.
-  All recipients will receive induction therapy with basiliximab or rATG and triple
 maintenance immunosuppression with TAC/MMF and corticosteroid.

 -  PB at 2 weeks and 1 year after transplantation will be performed using an 18-gauge
 needle under ultrasound guidance.

 -  Patients who will get PB can be the candidate of this study.

 -  Methylprednisolone 0.5 g daily for 3 days will be administered in patients with SCR.

 -  Information of enrolled patient including age, sex, height, body weight, serum
 creatinine level, modality of dialysis, duration of dialysis, panel reactive antibody,
 donor specific antibody, HLA mismatch, ABO incompatibility and history of previous
 transplantation will be collected. These data will be safely controlled by the person in
 charge. Patient name will be changed in to initials and registration number of hospital
 will be changed into new registration number of this study.

 -  laboratory tests including WBC, BUN, creatinine, FK level, MPA level, CMV virus DNA
 load, BK virus DNA load, urine nitrate, urine leukocyte esterase, urine BK virus DNA
 load, urine culture and chest X-ray will be checked on 14th post-operative day and every
 month until 1year after KT.

 -  Enrolled patients will be followed for 1 year and routinely undergo 1-year protocol
 biopsy.

 -  Within 1 year follow up period, clinical biopsy is performed when recipients' serum
 creatinine level raised more than 25% of baseline level.

 -  The primary end point

 -  Biopsy proven acute rejection event within 1 year after renal transplantation

 -  Histologic feature including persistent SCR (the presence of SCR at both 2-week and
 1-year protocol biopsy), chronic nephropathy at 1-year protocol biopsy.

 -  Graft kidney function estimated by serum creatinine level and eGFR

 -  The incidence of opportunistic infection including pneumonia, urinary tract infection,
 tuberculosis, fungal infection, and viral infections (such as cytomegalo, polyoma, and
 parvo-virus) within 1 year

 -  Secondary end points include effect of early detection of polioma BK virus associated
 nephritis (BKVAN) and relapsed underlying disease
Inclusion Criteria:

 -  Age 19 - 70 years.

 -  The patients who underwent renal transplantation.

 -  The patients who will show rejection in 2-week protocol biopsy with stable graft
 function will be included in this study.

 -  Stable function is defined as serum creatinine ≤1.5 mg/dl and ≤15% increase in
 serum creatinine in the 2 weeks before biopsy.

 Exclusion Criteria:

 -  The patients who had clinical uremic symptom within 2 weeks after kidney
 transplantation..

 -  The patients who had elevated serum creatinine level more than 1.5mg/dl or 15%
 compared to previous result.

 -  The patients' age under 19 years or over 70 years.

 -  The patients who underwent preoperative desensitization.

 -  The patients who had multiple organ transplantation.

 -  The patients who showed an allergic reaction to steroid.

 -  The patients who had psychologic disease (eg. depression) or history of psychologic
 medication.

 -  The patients who did not agree with a consent form.