The Impact of Early Protocol Biopsy in Kidney Transplant

April 5, 2016 updated by: Sung-Joo Kim, Samsung Medical Center

The Impact of Early Protocol Biopsy in Kidney Transplant Recipients Receiving TAC and MMF; a Prospective Observational Study

  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • 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

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center, Organ Transplant Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

kidney transplantation recipients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
subclinical rejection group
patients whose protocol biopsy outcome is subclinical rejection and treat with steroid pulse therapy (methylprednisolone)
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.
Other Names:
  • steroid pulse therapy
No rejection group
patients whose protocol biopsy outcome is normal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
biopsy proven acute rejection event
Time Frame: within 1 year after renal transplantation
within 1 year after renal transplantation
incidence of opportunistic infection
Time Frame: within 1 year after renal transplantation
within 1 year after renal transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
histologic feature at 1 year protocol biopsy
Time Frame: 1 year after renal transplantation
1 year after renal transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Sung Joo Kim, Professor, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

April 1, 2019

Study Completion (ANTICIPATED)

April 1, 2019

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (ESTIMATE)

April 11, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2016-02-108-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Renal Failure

Clinical Trials on methylprednisolone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe