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

End-stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04575077
• Other study ID #: 4-2020-0748
• Status: Recruiting
• Start date: September 16, 2020
• Est. completion date: August 2022

Study information

• Verified date: September 2020
• Source: Yonsei University
• Contact: Bon-Nyeo Koo, PhD
• Phone: 82-2-2228-2422
• Email: koobn[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2022
• Est. primary completion date: February 2022
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute kidney injury	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.)	6 months
Secondary	numbers of participants with abnormal laboratory values	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	1) 1 month before the surgery, 2) Postoperative day(POD) 1, 3) 2 weeks after the surgery
Secondary	the number of participants with wound infection		6 months after surgery
Secondary	major adverse cardiac event		6 months after surgery
Secondary	the number of participants who hospitalize again		6 months after surgery
Secondary	mortality		6 months after surgery