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NCT03134625 Clinical Trial

Metabolite Biomarkers Related to Acute Rejection in Kidney Transplantation

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03134625
Other study ID # 1606-069-771
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 28, 2016
Est. completion date July 31, 2023

Study information
Verified date May 2022
Source Seoul National University Hospital
Contact Jongwon Ha, MD, PhD
Phone +82-2-2072-2991
Email jwhamd@snu.ac.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date July 31, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary biomarker for acute rejection in kidney transplantation urine metabolite which is specific for kidney transplant rejection 1 year
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