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Urinary Transglutaminase 2 as a Biomarker for Kidney Allograft Fibrosis

NCT03487861 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2018-04-04

No results posted yet for this study

Summary

The aim of this study is to verify the ability of transglutaminase type 2 to predict rejection or chronic allograft nephropathy of renal allograft. On the basis of biomolecular mechanisms aggravating chronic allograft nephropathy, we eventually expect to develop the remedy to prevent chronic allograft nephropathy after kidney transplantation.

Conditions

  • Kidney Allograft Fibrosis
  • Kidney Transplant Failure and Rejection

Interventions

DIAGNOSTIC_TEST

observational(urinary biomarker for kidney allograft fibrosis)

After an informed consent is obtained, urine specimens will be collected prospectively before kidney transplantation (if available) and 3rd and 7th day, 1st, 3rd, and 6th month post-transplant. About 35\~50ml of urine sample is collected from each patient. For each urine specimen, 0.5 ml of a protease inhibitor mixture (5mM 4-(2-animoethyl) benzensulfonyl fluoride hydrolchloride, 2 μM Leupeptin-hemisulfate, and 3.3 mM Sodium azide) is added. To remove urinary sediments including whole cells, large membrane particles, and other debris, urine specimens are centrifuged at a rate of 4000 rpm for 15 minutes at 4 ℃. An aliquot of supernatant is stored at -80 ℃ until use. Urinary biomarkers including transglutaminase 2 are quantified using ELISA or CBA. In addition, urinary exosomes are isolated and analyzed. When a for-cause biopsy is done for some patients, the correlation between biomarkers and pathologic diagnosis will be assessed.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • SUNG SHIN, MD, PhD · Asan Medical Center

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-29
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03487861 on ClinicalTrials.gov