The Role of Hepcidin as a Biomarker to Predict Successful Renal Transplantation

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04575077
Collaborator
(none)
200
1
22.5
8.9

Study Details

Study Description

Brief Summary

High hepcidin concentrations indicate that iron is blocked from secretion from the reservoir. Hepcidin may be useful in prediction functional iron utilization in renal failure patients. Hepcidin is also associated with chronic renal failure and residual renal function in dialysis patients. Recent studies have shown that hepcidin is a potential marker of impaired renal function in a rat model of chronic nephropathy.

The purpose of this study was to investigate the relationship between preoperative hepcidin levels and the incidence of success rate of kidney transplantation in patients with end-stage renal failure undergoing kidney transplantation surgery. The study is a prospective single-group observational study that analyzes hepcidin as a biomarker.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    POD-1 : Researchers will meet patients scheduled for surgery and explain the study. (enroll) the operation date : The patient will sign the consent form. Researchers will collect the blood sample from the patient for testing hepcidin during the operation and record laboratory data performed before surgery POD 1: laboratory test discharge date : laboratory test 6 months after surgery ; Researchers will determine the graft failure of the patient.

    • laboratory test ; reticulocyte count, Hb, plasma hepcidin, iron profiles (serum iron, serum ferritin, total iron-binding capacity, transferrin, transferrin saturation), coagulation profiles (PT, PTT), routine urinary analysis, and chemical profiles (aspartate aminotransferase (AST)/alanine aminotransaminase (ALT), serum creatinine, electrolytes, C-reactive protein (CRP), estimated glomerular filtration rate (GFR)), ESR, cystatin C, NGAL, pro BNP, troponin T and urinary analysis

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Role of Hepcidin as a Biomarker to Predict Successful Renal Transplantation
    Actual Study Start Date :
    Sep 16, 2020
    Anticipated Primary Completion Date :
    Feb 1, 2022
    Anticipated Study Completion Date :
    Aug 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. acute kidney injury [6 months]

      AKIN Criteria have only three stages of AKI (Stages I-III) which generally correspond to RIFLE stages R, I, and F. The AKIN group claims an advantage over the RIFLE criteria in that it has a lower threshold for defining an individual as Stage I AKI (only 0.3 mg/dL increase OR a 1.5X increase over baseline is required to meet this definition in AKIN; in RIFLE one requires a 1.5X increase over baseline. Both definitions can also be met by urine output criteria as well.)

    Secondary Outcome Measures

    1. numbers of participants with abnormal laboratory values [1) 1 month before the surgery, 2) Postoperative day(POD) 1, 3) 2 weeks after the surgery]

      Laboratory test(reticulocyte count, Hb, plasma hepcidin, iron profiles (serum iron, serum ferritin, total iron-binding capacity, transferrin, transferrin saturation), coagulation profiles (PT, PTT), and chemical profiles (aspartate aminotransferase (AST)/alanine aminotransaminase (ALT), serum creatinine, electrolytes, C-reactive protein (CRP), estimated glomerular filtration rate (GFR)), ESR, cystatin C, NGAL, pro BNP, troponin T), routine urinary analysis

    2. the number of participants with wound infection [6 months after surgery]

    3. major adverse cardiac event [6 months after surgery]

    4. the number of participants who hospitalize again [6 months after surgery]

    5. mortality [6 months after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 99 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    1. The patients who plan to undergo kidney transplantation

    2. ASA III-IV

    3. adult over 19 years old

    Exclusion Criteria:
    1. emergent case

    2. heart disease

    3. arrhythmia

    4. BMI >30kg/m2

    5. allergy to some drugs

    6. if other co-operation is planned

    7. foreigner

    8. Illiteracy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Bon-Nyeo Koo, PhD, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT04575077
    Other Study ID Numbers:
    • 4-2020-0748
    First Posted:
    Oct 5, 2020
    Last Update Posted:
    Oct 5, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2020