The Recipients Undergoing Liver TransplantationNCT03344380
Identification of Genetic Polymorphism Related to Acute Kidney Injury After Liver Transplantation Through Genome-wide Association Study (GWAS) in Korean Population
An observational study of The Recipients Undergoing Liver Transplantation, run by Yonsei University at 1 site in South Korea.
Trial summary
Some of the liver transplantation recipients experience postoperative acute kidney injury due to various causes including genetic factors. Prevention of postoperative acute kidney injury is essential for postoperative care in liver transplantation recipients. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- The Recipients Undergoing Liver Transplantation
- How many people
- 330 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2017to Dec 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for liver transplantation
Who may be able to join
- 1) adult patients scheduled for liver transplantation
Who cannot join
- Patients on dialysis
- patients not able to read, or understand the consent form
- ethnicity, other than asian
- patients refusal
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 03722
Seung Ho Choi, MD, +82-2-2228-2420, csho99@yuhs.ac
About this study
Some of the liver transplantation recipients experience postoperative acute kidney injury due to various causes including genetic factors. Prevention of postoperative acute kidney injury is essential for postoperative care in liver transplantation recipients. The aim of this study is to investigate the relationship between gene polymorphisms and the occurrence of acute kidney injury after liver transplantation by performing genome-wide association study (GWAS).
- Keywords
- Gene polymorphism, acute kidney injury, liver transplantation
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Adult patients undergoing liver transplantation will be included and followed up during the first 72 hours post-liver transplantation in order to confirm the development of acute kidney injury. The patients will be divided into two groups (AKI group vs. non-AKI group) according to the development of acute kidney injury. The GWAS will be performed with the blood obtained from enrolled patients. | |
| Retrospective cohort | In previous study performed in adult patients undergoing liver transplantation (NCT02489474, 4-2015-0411), we enrolled patients and collected data regarding the development of acute kidney injury during the first 72 hours post-liver transplantation. Among these patients enrolled in this previous study, only patients who agreed to additional use of the blood sample for research purposes will be included in the present study. The GWAS will be performed with the blood obtained from enrolled patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury after liver transplantation
The development of acute kidney injury is defined by the following definition: 50% increase in SCr from the baseline (preoperative value) or a 0.3 mg/dl increase from baseline within 48 h without urine output. The development of acute kidney injury after liver transplantation could correlate with gene polymorphisms, which have been known to be associated with postoperative acute kidney injury.
Measured: Participants will be followed up during the first 72 hours post-liver transplantation in order to confirm the development of acute kidney injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Nov 2017
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Recipients Undergoing Liver TransplantationStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344380
- Sponsor's protocol ID
- 4-2017-0888
- Status last verified
- Jan 2019
- First submitted
- 13 Nov 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genetic Polymorphism Related to Acute Kidney Injury After Liver Transplantation Through Genome-wide Association Study (GWAS) in Korean Population
- ClinicalTrials.gov ID
- NCT03344380
- Acronym / sponsor ID
- 4-2017-0888
- Keywords
- Gene polymorphism, acute kidney injury, liver transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Nov 2017 (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.
Some of the liver transplantation recipients experience postoperative acute kidney injury due to various causes including genetic factors. Prevention of postoperative acute kidney injury is essential for postoperative care in liver transplantation recipients. The aim of this study is to investigate the relationship between gene polymorphisms and the occurrence of acute kidney injury after liver transplantation by performing genome-wide association study (GWAS).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | –Adult patients undergoing liver transplantation will be included and followed up during the first 72 hours post-liver transplantation in order to confirm the development of acute kidney injury. The patients will be divided into two groups (AKI group vs. non-AKI group) according to the development of acute kidney injury. The GWAS will be performed with the blood obtained from enrolled patients. |
| Retrospective cohort | – | –In previous study performed in adult patients undergoing liver transplantation (NCT02489474, 4-2015-0411), we enrolled patients and collected data regarding the development of acute kidney injury during the first 72 hours post-liver transplantation. Among these patients enrolled in this previous study, only patients who agreed to additional use of the blood sample for research purposes will be included in the present study. The GWAS will be performed with the blood obtained from enrolled patients. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for liver transplantation
Key inclusion criteria (1 listed)
- 1) adult patients scheduled for liver transplantation
Key exclusion criteria (4 listed)
- Patients on dialysis
- patients not able to read, or understand the consent form
- ethnicity, other than asian
- patients refusal
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 after liver transplantation
Time frame: Participants will be followed up during the first 72 hours post-liver transplantation in order to confirm the development of acute kidney injury.
The development of acute kidney injury is defined by the following definition: 50% increase in SCr from the baseline (preoperative value) or a 0.3 mg/dl increase from baseline within 48 h without urine output. The development of acute kidney injury after liver transplantation could correlate with gene polymorphisms, which have been known to be associated with postoperative acute kidney injury.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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.
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 The Recipients Undergoing Liver Transplantation, 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 1 inclusion and 4 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 11 Jan 2019. 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 Seung Ho Choi, MD (+82-2-2228-2420, csho99@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 after liver transplantation (time frame: Participants will be followed up during the first 72 hours post-liver transplantation in order to confirm the development of acute kidney injury.). 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 11 Jan 2019.