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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04575077
Enrollment
200
Registered
2020-10-05
Start date
2020-09-16
Completion date
2022-08-31
Last updated
2020-10-05

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

Conditions

End-stage Renal Disease

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.

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

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 99 Years

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

Design outcomes

Primary

MeasureTime frameDescription
acute kidney injury6 monthsAKIN 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

MeasureTime frameDescription
numbers of participants with abnormal laboratory values1) 1 month before the surgery, 2) Postoperative day(POD) 1, 3) 2 weeks after the surgeryLaboratory 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 infection6 months after surgery
major adverse cardiac event6 months after surgery
the number of participants who hospitalize again6 months after surgery
mortality6 months after surgery

Countries

South Korea

Contacts

Primary ContactBon-Nyeo Koo, PhD
koobn@yuhs.ac82-2-2228-2422

Outcome results

None listed

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