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NCT Number: NCT03764670

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Kidney transplantation
  • 20-65 years old
  • Receiving tacrolimus-based immunosuppressants
  • Were recruited in a previous trial

Exclusion criteria

  • Human immunodeficiency virus-positive status
  • Retransplantation or multiorgan transplantation
  • Non-Asian

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Patient survival

    Time frame: 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)

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Influence of Genetic and Clinical Factors on Clinical Outcomes of Kidney Transplant Patients With Tacrolimus Based Immunosuppression

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 5, 2018
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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