Metabolite Biomarkers Related to Acute Rejection in Kidney Transplantation

• Conditions: Kidney Transplantation; Rejection Acute Renal

• Registration Number: NCT03134625
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-28
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-20
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
biomarker for acute rejection in kidney transplantation	1 year	urine metabolite which is specific for kidney transplant rejection

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of