NCT03134625

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

7.1 years

First QC Date

April 26, 2017

Last Update Submit

May 19, 2022

Conditions

Kidney TransplantationRejection Acute Renal

Keywords

metabolomicsbiomarkeracute rejection

Outcome Measures

Primary Outcomes (1)

  • biomarker for acute rejection in kidney transplantation

    urine metabolite which is specific for kidney transplant rejection

    1 year

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

Central Study Contacts

Jongwon Ha, MD, PhD

CONTACT

+82-2-2072-2991jwhamd@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 1, 2017

Study Start

June 28, 2016

Primary Completion

July 30, 2023

Study Completion

July 31, 2023

Last Updated

May 20, 2022

Record last verified: 2022-05

Locations

KR(1)