The Impact of Early Protocol Biopsy in Kidney Transplant

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.