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Genetic Factors on Outcomes of Kidney Transplant Patients With Tacrolimus-based Therapy

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03764670
Collaborator
(none)
98
Enrollment
1
Location
21.7
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    98 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    The Influence of Genetic and Clinical Factors on Clinical Outcomes of Kidney Transplant Patients With Tacrolimus Based Immunosuppression
    Actual Study Start Date :
    Nov 30, 2018
    Actual Primary Completion Date :
    Oct 3, 2019
    Actual Study Completion Date :
    Sep 22, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Acute rejection [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

    2. Graft survival [From post-transplantation to Dec 31, 2017]

      The incidence of graft loss during the follow-up time, estimated with Kaplan-Meier survival analysis

    Secondary Outcome Measures

    1. Patient survival [From post-transplantation to Dec 31, 2017]

      The incidence of death during the follow-up time (number of events or frequency)

    2. Kidney function measured by estimated glomerular filtration rate (eGFR) [From post-transplantation to Dec 31, 2017]

      Kidney function during the follow-up time measured by eGFR (MDRD 4-variable equation, in mL/min/1.73 m^2).

    3. Incidence of adverse events, including post-transplant diabetes mellitus, deterioration of liver function, cancer, infection and hyperlipidemia [From post-transplantation to Dec 31, 2017]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Kidney transplantation

    2. 20-65 years old

    3. Receiving tacrolimus-based immunosuppressants

    4. Were recruited in a previous trial

    Exclusion Criteria:

    1. Human immunodeficiency virus-positive status

    2. Retransplantation or multiorgan transplantation

    3. Non-Asian

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Meng-Kun Tsai, Professor, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03764670
    Other Study ID Numbers:
    • 201809018RINB
    First Posted:
    Dec 5, 2018
    Last Update Posted:
    Mar 12, 2021
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital
    tacrolimus
    clinical outcomes
    genetic polymorphism
    clinical factors

    Study Results

    No Results Posted as of Mar 12, 2021