Liver TransplantationNCT03800576
Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression
An observational study of Liver Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Genetic polymorphism and numerous clinical factors could influence tacrolimus pharmacokinetics, which led to large inter-and intra-individual variability.Since its narrow therapeutic range,predicting therapeutic outcome and individualized dosage remains to be a challenge. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Liver Transplantation
- How many people
- 113 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jun 2019to 22 Sep 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent living donor liver transplantation (LDLT) during 2008 to 2017 in National Taiwan University Hospital and received tacrolimus-based immunosuppression.
Who may be able to join
- patients who underwent living-donor liver transplantation during January 2008 to December 2017
- at the age of 20-65
- with tacrolimus-based immunosuppression after liver transplant for at least 6 months.
Who cannot join
- retransplantation
- multi-organ transplantation
- human immunodeficiency virus (HIV) positive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Genetic and Clinical Factors on Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression
Genetic polymorphism and numerous clinical factors could influence tacrolimus pharmacokinetics, which led to large inter-and intra-individual variability.Since its narrow therapeutic range,predicting therapeutic outcome and individualized dosage remains to be a challenge. The study's objective is to identify the genetic and clinical factors that can influence clinical outcome in liver transplant.
Read the detailed description
A great number of studies had found significant correlation between tacrolimus pharmacokinetics and gene polymorphism. However, previous studies on the correlation between genetic factors and clinical outcome were controversial. Furthermore, most studies focused on single genetic polymorphism and clinical outcome, and very limited studies took multiple genetic factors and clinical factors into account.
This is a retrospective study. Eligible patients were those who had signed informed consent for genetic study in previous research projects ( IRB approval number：201512005RINC and 201612023RIND ). The present study will collect laboratory data, concurrent medications, and therapeutic drug monitoring (TDM) data. Patient survival, graft survival, acute rejection and tacrolimus-associated adverse events will be assessed.
- Conditions
- Liver Transplantation
- Keywords
- tacrolimus, liver transplant, gene polymorphism, immunosuppressant
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients with biopsy proven acute rejection (BPAR)
Incidence of BPAR will be estimated with Kaplan-Meier analysis
Measured: up to 12 months after liver transplantation
Graft survival
incidence of graft loss will be estimated Kaplan-Meier analysis
Measured: up to 9 years after liver transplantation
Secondary outcomes (2)
Number of patients with tacrolimus-associated adverse events
Common adverse events of tacrolimus such as nephrotoxicity, post-transplant diabetes mellitus, hypertension, infection, hyperlipidemia and malignancy.
- nephrotoxicity：decreased renal function estimated by glomerular filtration rate(GFR) using MDRD 4-Variable Equation
- Post-transplant diabetes mellitus：defined by diagnosis and the use of antihyperglycemic agents, laboratory data including blood sugar(mg/dL) and hemoglobin A1c (percentage)
- hypertension：defined by diagnosis and the use of antihypertensive agents, laboratory data including blood pressure(mmHg)
- infection：defined by diagnosis of infection and the use of antiinfective agents
- Hyperlipidemia：defined by diagnosis and the use of lipid-lowering agents, laboratory data including LDL (mg/dL), HDL (mg/dL) and total cholesterol (mg/dL)
- malignancy：incidence of cancer
Measured: up to 9 years after liver transplantation
Patient survival
incidence of death
Measured: up to 9 years after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start6 Jun 2019
- Primary completion8 Oct 2019
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rey-Heng Hu, Professor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800576
- Sponsor's protocol ID
- 201812015RINC
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2019
- Last updated
- 16 Mar 2021
- 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Genetic and Clinical Factors on Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression
- ClinicalTrials.gov ID
- NCT03800576
- Acronym / sponsor ID
- 201812015RINC
- Conditions
- Liver Transplantation
- Keywords
- tacrolimus, liver transplant, gene polymorphism, immunosuppressant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 11 Jan 2019 (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.
Genetic polymorphism and numerous clinical factors could influence tacrolimus pharmacokinetics, which led to large inter-and intra-individual variability.Since its narrow therapeutic range,predicting therapeutic outcome and individualized dosage remains to be a challenge. The study's objective is to identify the genetic and clinical factors that can influence clinical outcome in liver transplant.
Detailed description
A great number of studies had found significant correlation between tacrolimus pharmacokinetics and gene polymorphism. However, previous studies on the correlation between genetic factors and clinical outcome were controversial. Furthermore, most studies focused on single genetic polymorphism and clinical outcome, and very limited studies took multiple genetic factors and clinical factors into account.
This is a retrospective study. Eligible patients were those who had signed informed consent for genetic study in previous research projects ( IRB approval number：201512005RINC and 201612023RIND ). The present study will collect laboratory data, concurrent medications, and therapeutic drug monitoring (TDM) data. Patient survival, graft survival, acute rejection and tacrolimus-associated adverse events will be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent living donor liver transplantation (LDLT) during 2008 to 2017 in National Taiwan University Hospital and received tacrolimus-based immunosuppression.
Key inclusion criteria (3 listed)
- patients who underwent living-donor liver transplantation during January 2008 to December 2017
- at the age of 20-65
- with tacrolimus-based immunosuppression after liver transplant for at least 6 months.
Key exclusion criteria (3 listed)
- retransplantation
- multi-organ transplantation
- human immunodeficiency virus (HIV) positive.
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
Incidence of patients with biopsy proven acute rejection (BPAR)
Time frame: up to 12 months after liver transplantation
Incidence of BPAR will be estimated with Kaplan-Meier analysis
Graft survival
Time frame: up to 9 years after liver transplantation
incidence of graft loss will be estimated Kaplan-Meier analysis
2 secondary outcomes
Number of patients with tacrolimus-associated adverse events
Time frame: up to 9 years after liver transplantation
Patient survival
Time frame: up to 9 years after liver transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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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.
Rey-Heng Hu, Professor principal investigator
National Taiwan University 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 Liver Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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: finished, as of the sponsor's last update on 16 Mar 2021. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients with biopsy proven acute rejection (BPAR) (time frame: up to 12 months after liver transplantation). The study lists 2 primary outcomes in all. 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 16 Mar 2021.