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The Impact of Early Protocol Biopsy in Kidney Transplant

NCT02733510 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2016-04-11

No results posted yet for this study

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.

Conditions

  • Chronic Renal Failure

Interventions

DRUG

methylprednisolone

Steroid pulse therapy : Methylprednisolone 0.5 g daily for 3 days, followed by a tapered dose of 60 mg per day for a period of five days.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Sung Joo Kim, Professor · Samsung Medical Center

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02733510 on ClinicalTrials.gov