Kidney TransplantationNCT02707822
The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism and Other Factors on Tacrolimus Blood Concentration
An observational study of Kidney Transplantation and Liver Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of the study is to identify factors that may influence tacrolimus (TAC) pharmacokinetics, and the impact of gene polymorphism (ABCB1, CYP3A4, CYP3A5, POR) on pharmacokinetics of TAC in Taiwanese. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Kidney Transplantation, Liver Transplantation
- What is being tested?
- Clinical and genetic factors
- How many people
- 440 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Dec 2018
- 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: Renal or liver transplant recipients who underwent transplantation at National Taiwan University Hospital, and were treated with tacrolimus.
Who may be able to join
- kidney transplants or liver transplants
- 20 - 65 years old
- receiving tacrolimus as immunosuppressive drugs
Who cannot join
- Human immunodeficiency virus-positive status
- Retransplantation or multiorgan transplantation
- non-Asian
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Meng-Kun Tsai, +886-972651461, mengkuntsai@ntu.edu.tw
About this study
The purpose of the study is to identify factors that may influence tacrolimus (TAC) pharmacokinetics, and the impact of gene polymorphism (ABCB1, CYP3A4, CYP3A5, POR) on pharmacokinetics of TAC in Taiwanese.
Read the detailed description
TAC is one of the most important immunosuppressive agents for organ transplantation. In some patients the dose and concentration of TAC are difficult to adjust because of its narrow therapeutic index and variable pharmacokinetics.
Many factors affect the pharmacokinetics of TAC. Literature suggests that ABCB1, CYP3A4, CYP3A5, POR gene polymorphisms may affect the pharmacokinetics of TAC. In addition, the distribution of TAC is affected by hematocrit and albumin concentrations. The pharmacokinetics of TAC may also be affected by total protein, total bilirubin, creatinine, AST, ALT, gender, age, drug interactions, and so on.
This study intends to analyze the influence of various factors, including drugs, on the pharmacokinetics of TAC.
- Conditions
- Kidney Transplantation, Liver Transplantation
- Being tested
- Clinical and genetic factors
- Keywords
- tacrolimus, pharmacokinetics, gene polymorphism, clinical factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and genetic factorsOther
| Study group | Role | What they receive |
|---|---|---|
| kidney or liver transplantation | Renal or liver transplant recipients with tacrolimus as immunosuppressive drugs. Receives: Other: Clinical and genetic factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-normalized tacrolimus concentration
Measured: Within the first 6 months post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng-Kun Tsai, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707822
- Sponsor's protocol ID
- 201512005RINC
- Status last verified
- Mar 2016
- First submitted
- 9 Mar 2016
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism and Other Factors on Tacrolimus Blood Concentration
- ClinicalTrials.gov ID
- NCT02707822
- Acronym / sponsor ID
- 201512005RINC
- Conditions
- Kidney Transplantation, Liver Transplantation
- Keywords
- tacrolimus, pharmacokinetics, gene polymorphism, clinical factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Mar 2016 (estimated)
- 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.
The purpose of the study is to identify factors that may influence tacrolimus (TAC) pharmacokinetics, and the impact of gene polymorphism (ABCB1, CYP3A4, CYP3A5, POR) on pharmacokinetics of TAC in Taiwanese.
Detailed description
TAC is one of the most important immunosuppressive agents for organ transplantation. In some patients the dose and concentration of TAC are difficult to adjust because of its narrow therapeutic index and variable pharmacokinetics.
Many factors affect the pharmacokinetics of TAC. Literature suggests that ABCB1, CYP3A4, CYP3A5, POR gene polymorphisms may affect the pharmacokinetics of TAC. In addition, the distribution of TAC is affected by hematocrit and albumin concentrations. The pharmacokinetics of TAC may also be affected by total protein, total bilirubin, creatinine, AST, ALT, gender, age, drug interactions, and so on.
This study intends to analyze the influence of various factors, including drugs, on the pharmacokinetics of TAC.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| kidney or liver transplantation | – | Other: Clinical and genetic factorsRenal or liver transplant recipients with tacrolimus as immunosuppressive drugs. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal or liver transplant recipients who underwent transplantation at National Taiwan University Hospital, and were treated with tacrolimus.
Key inclusion criteria (3 listed)
- kidney transplants or liver transplants
- 20 - 65 years old
- receiving tacrolimus as immunosuppressive drugs
Key exclusion criteria (3 listed)
- Human immunodeficiency virus-positive status
- Retransplantation or multiorgan transplantation
- non-Asian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and genetic factors | Other | kidney or liver transplantation |
Primary outcome
Dose-normalized tacrolimus concentration
Time frame: Within the first 6 months post-transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
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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.
Meng-Kun Tsai 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 Kidney Transplantation and 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: status not confirmed, as of the sponsor's last update on 14 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fe-Lin Lin Wu (+886-2-3366 8784, flwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-normalized tacrolimus concentration (time frame: Within the first 6 months post-transplantation). 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 14 Mar 2016.