Clinical trial NCT04575077: The Role of Hepcidin as a Biomarker to Predict Successful Renal Transplantation
Official title: The Role of Hepcidin as a Biomarker to Predict Successful Renal Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End-stage Renal Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with end-stage kidney disease who are expected to undergo kidney transplantation

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

Eligibility criteria: 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

Primary outcomes:
measure: acute kidney injury
timeFrame: 6 months
Secondary outcomes:
measure: numbers of participants with abnormal laboratory values
timeFrame: 1) 1 month before the surgery, 2) Postoperative day(POD) 1, 3) 2 weeks after the surgery
measure: the number of participants with wound infection
timeFrame: 6 months after surgery
measure: major adverse cardiac event
timeFrame: 6 months after surgery
measure: the number of participants who hospitalize again
timeFrame: 6 months after surgery
measure: mortality
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Bon-Nyeo Koo, PhD
role: PRINCIPAL_INVESTIGATOR
References: