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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2022

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

Clinical Trial Outcome Measures

Primary Measures

  • acute kidney injury
    • Time Frame: 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 Measures

  • numbers of participants with abnormal laboratory values
    • Time Frame: 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
  • the number of participants with wound infection
    • Time Frame: 6 months after surgery
  • major adverse cardiac event
    • Time Frame: 6 months after surgery
  • the number of participants who hospitalize again
    • Time Frame: 6 months after surgery
  • mortality
    • Time Frame: 6 months after surgery

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 99 Years

Investigator Details

  • Lead Sponsor
    • Yonsei University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bon-Nyeo Koo, PhD, Principal Investigator, Severance Hospital
  • Overall Contact(s)
    • Bon-Nyeo Koo, PhD, 82-2-2228-2422, koobn@yuhs.ac

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