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Urinary Transglutaminase 2 as a Biomarker for Kidney Allograft Fibrosis

Development of a Diagnostic Kit for Urinary Transglutaminase 2 as a Biomarker for Kidney Allograft Fibrosis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03487861
Enrollment
1000
Registered
2018-04-04
Start date
2017-08-29
Completion date
2020-12-31
Last updated
2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Allograft Fibrosis, Kidney Transplant Failure and Rejection

Keywords

transglutaminase type 2, kidney transplantation, chronic allograft nephropathy, biomarker

Brief 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.

Interventions

DIAGNOSTIC_TESTobservational(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

Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* kidney transplant recipients from cadaveric or living donors * kidney transplant recipients who take immunosuppressants regularly * kidney transplant recipients who voluntarily agree to participate in this trial

Exclusion criteria

* multiorgan transplant recipients * kidney transplant recipients with active infection * kidney transplant recipients with alcohol or drug addiction

Design outcomes

Primary

MeasureTime frame
change of level of urinary transglutaminase 23 days, 7 days, 1 month, 3 months, 6 months post-transplant

Countries

South Korea

Contacts

Primary ContactSUNG SHIN, MD, PhD
sshin@amc.seoul.kr82-2-3010-3964

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026