Kidney TransplantationNCT03764670
Genetic Factors on Outcomes of Kidney Transplant Patients With Tacrolimus-based Therapy
An observational study of Kidney Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to identify the influence of genetic and clinical factors on the clinical outcomes of kidney transplant patients with tacrolimus (TAC) based immunosuppression in Taiwan. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Kidney Transplantation
- How many people
- 98 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Nov 2018to 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: Kidney transplant recipients who underwent transplantation at National Taiwan University Hospital, and received tacrolimus based immunosupression
Who may be able to join
- Kidney transplantation
- 20-65 years old
- Receiving tacrolimus-based immunosuppressants
- Were recruited in a previous trial
Who cannot join
- Human immunodeficiency virus-positive status
- Retransplantation or multiorgan transplantation
- Non-Asian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Genetic and Clinical Factors on Clinical Outcomes of Kidney Transplant Patients With Tacrolimus Based Immunosuppression
The purpose of this study is to identify the influence of genetic and clinical factors on the clinical outcomes of kidney transplant patients with tacrolimus (TAC) based immunosuppression in Taiwan.
Read the detailed description
Tacrolimus (TAC) is the most important immunosuppressants for maintenance therapy after kidney transplantation. Many genetic and clinical factors had been found to have effect on TAC pharmacokinetics (PK). Whether these factors affect clinical outcomes is still controversial.
In this retrospective study, investigators will review records of kidney transplant patients with TAC based immunosuppression recruited from a previous study (IRB approval number: 201512005RINC) to understand the influence of clinical and genetic factors on their 3-years clinical outcomes, including biopsy-proven acute rejection, patient survival, graft survival and safety issues of kidney transplant patients.
- Conditions
- Kidney Transplantation
- Keywords
- tacrolimus, clinical outcomes, genetic polymorphism, clinical factors
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute rejection
The incidence of acute rejection within the first 1 year post-transplantation, estimated with Kaplan-Meier survival analysis
Measured: Within the first 1 year post-transplantation
Graft survival
The incidence of graft loss during the follow-up time, estimated with Kaplan-Meier survival analysis
Measured: From post-transplantation to Dec 31, 2017
Secondary outcomes (3)
Patient survival
The incidence of death during the follow-up time (number of events or frequency)
Measured: From post-transplantation to Dec 31, 2017
Kidney function measured by estimated glomerular filtration rate (eGFR)
Kidney function during the follow-up time measured by eGFR (MDRD 4-variable equation, in mL/min/1.73 m^2).
Measured: From post-transplantation to Dec 31, 2017
Incidence of adverse events, including post-transplant diabetes mellitus, deterioration of liver function, cancer, infection and hyperlipidemia
The incidence of infection and cancer in number of events or frequency in percentage.
The change of liver function : measured by aspartate aminotransferase (AST in U/L), alanine aminotransferase (ALT in U/L), and total bilirubin in mg/dL.
Hyperlipidemia: identified by diagnosis and the use of lipid-lowering agents, with follow-up of LDL in mg/dL, HDL in mg/dL, and total cholesterol in mg/dL.
Post-transplant diabetes mellitus: identified by diagnosis and the use of antihyperglycemic agents, with follow-up of hemoglobin A1c in percentage and blood glucose in mg/dL.
Measured: From post-transplantation to Dec 31, 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start30 Nov 2018
- Primary completion3 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 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
- Time perspective
- Retrospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng-Kun Tsai, Professor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764670
- Sponsor's protocol ID
- 201809018RINB
- Status last verified
- Sep 2020
- First submitted
- 15 Nov 2018
- Last updated
- 12 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 12 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 Outcomes of Kidney Transplant Patients With Tacrolimus Based Immunosuppression
- ClinicalTrials.gov ID
- NCT03764670
- Acronym / sponsor ID
- 201809018RINB
- Conditions
- Kidney Transplantation
- Keywords
- tacrolimus, clinical outcomes, genetic polymorphism, clinical factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 5 Dec 2018 (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.
The purpose of this study is to identify the influence of genetic and clinical factors on the clinical outcomes of kidney transplant patients with tacrolimus (TAC) based immunosuppression in Taiwan.
Detailed description
Tacrolimus (TAC) is the most important immunosuppressants for maintenance therapy after kidney transplantation. Many genetic and clinical factors had been found to have effect on TAC pharmacokinetics (PK). Whether these factors affect clinical outcomes is still controversial.
In this retrospective study, investigators will review records of kidney transplant patients with TAC based immunosuppression recruited from a previous study (IRB approval number: 201512005RINC) to understand the influence of clinical and genetic factors on their 3-years clinical outcomes, including biopsy-proven acute rejection, patient survival, graft survival and safety issues of kidney transplant patients.
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
- Kidney transplant recipients who underwent transplantation at National Taiwan University Hospital, and received tacrolimus based immunosupression
Key inclusion criteria (4 listed)
- Kidney transplantation
- 20-65 years old
- Receiving tacrolimus-based immunosuppressants
- Were recruited in a previous trial
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.
Primary outcome
Acute rejection
Time frame: Within the first 1 year post-transplantation
The incidence of acute rejection within the first 1 year post-transplantation, estimated with Kaplan-Meier survival analysis
Graft survival
Time frame: From post-transplantation to Dec 31, 2017
The incidence of graft loss during the follow-up time, estimated with Kaplan-Meier survival analysis
3 secondary outcomes
Patient survival
Time frame: From post-transplantation to Dec 31, 2017
Kidney function measured by estimated glomerular filtration rate (eGFR)
Time frame: From post-transplantation to Dec 31, 2017
Incidence of adverse events, including post-transplant diabetes mellitus, deterioration of liver function, cancer, infection and hyperlipidemia
Time frame: From post-transplantation to Dec 31, 2017
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 12 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.
Meng-Kun Tsai, 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 Kidney 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 4 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 12 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?
Acute rejection (time frame: Within the first 1 year post-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 12 Mar 2021.