End-stage Renal DiseaseNCT04575077
The Role of Hepcidin as a Biomarker to Predict Successful Renal Transplantation
An observational study of End-stage Renal Disease, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- End-stage Renal Disease
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Sep 2020to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- All sexes
- Adult, Older adult
Study population: Patients with end-stage kidney disease who are expected to undergo kidney transplantation
Who may be able to join
- The patients who plan to undergo kidney transplantation
- ASA III-IV
- adult over 19 years old
Who cannot join
- emergent case
- heart disease
- arrhythmia
- BMI >30kg/m2
- allergy to some drugs
- if other co-operation is planned
- foreigner
- Illiteracy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Severance Hospital
Seoul
Bon-Nyeo Koo, PhD, 82-2-2228-2422, koobn@yuhs.ac
About this study
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.
Read the 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
- Conditions
- End-stage Renal Disease
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 6 months
Secondary outcomes (5)
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
Measured: 1) 1 month before the surgery, 2) Postoperative day(POD) 1, 3) 2 weeks after the surgery
the number of participants with wound infection
Measured: 6 months after surgery
major adverse cardiac event
Measured: 6 months after surgery
the number of participants who hospitalize again
Measured: 6 months after surgery
mortality
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start16 Sep 2020
- Primary completionFeb 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bon-Nyeo Koo, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575077
- Sponsor's protocol ID
- 4-2020-0748
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Hepcidin as a Biomarker to Predict Successful Renal Transplantation
- ClinicalTrials.gov ID
- NCT04575077
- Acronym / sponsor ID
- 4-2020-0748
- Conditions
- End-stage Renal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with end-stage kidney disease who are expected to undergo kidney transplantation
Key inclusion criteria (3 listed)
- The patients who plan to undergo kidney transplantation
- ASA III-IV
- adult over 19 years old
Key exclusion criteria (8 listed)
- emergent case
- heart disease
- arrhythmia
- BMI >30kg/m2
- allergy to some drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.)
5 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for End-stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bon-Nyeo Koo, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bon-Nyeo Koo, PhD (82-2-2228-2422, koobn@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute kidney injury (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.