Metabolite Biomarkers Related to Acute Rejection in Kidney Transplantation

May 19, 2022 updated by: Seoul National University Hospital

Identification of Metabolite Biomarkers Related to Acute Rejection of Patients With Kidney Transplantation

The development of acute rejection can only be considered in cases with increasing serum creatinine in patients with kidney transplantation. However, the serum creatinine itself is not specific but also accurate for detection of acute rejection. So The specific biomarker is required for acute rejection of kidney transplant. In this study, the investigators will enroll 200 consecutive kidney transplant patients in Seoul National University Hospital and follow up. Serial collection of urine and serum will be done. Acute rejection specific urine metabolite will be found by LC MS/MS.

Study Overview

Status

Recruiting

Conditions

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 Contact

  • Name: Jongwon Ha, MD, PhD
  • Phone Number: +82-2-2072-2991
  • Email: jwhamd@snu.ac.kr

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population includes low or moderate risk kidney transplantation. They should have triple immunosuppression.

Description

Inclusion Criteria:

  • Kidney transplant patients in Seoul National University Hospital
  • Patients with triple maintenance immunosuppression including Tacrolimus, mycophenolate and steroid

Exclusion Criteria:

  • History of other organ transplantation
  • ABOi and/or crossmatch(+) transplantation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biomarker for acute rejection in kidney transplantation
Time Frame: 1 year
urine metabolite which is specific for kidney transplant rejection
1 year

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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 (Actual)

June 28, 2016

Primary Completion (Anticipated)

July 30, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1606-069-771

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.

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