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

NCT04575077 | Unknown

• 1 other identifier: 4-2020-0748
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• numbers of participants with abnormal laboratory values

  1) 1 month before the surgery, 2) Postoperative day(POD) 1, 3) 2 weeks after the surgery

• the number of participants with wound infection

  6 months after surgery

• major adverse cardiac event

  6 months after surgery

• the number of participants who hospitalize again

  6 months after surgery

• mortality

  6 months after surgery

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with end-stage kidney disease who are expected to undergo kidney transplantation

You may qualify if:

• The patients who plan to undergo kidney transplantation
• ASA III-IV
• adult over 19 years old

You may not qualify if:

• emergent case
• heart disease
• arrhythmia
• BMI \>30kg/m2
• allergy to some drugs
• if other co-operation is planned
• foreigner
• Illiteracy

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bon-Nyeo Koo, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bon-Nyeo Koo, PhD

CONTACT

82-2-2228-2422; koobn@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 5, 2020
• Study Start: September 16, 2020
• Primary Completion: February 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)