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

National Taiwan University Hospital98 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Kidney Transplantation

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Acute rejection

The incidence of acute rejection within the first 1 year post-transplantation, estimated with Kaplan-Meier survival analysis

Time frame: 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

Time frame: From post-transplantation to Dec 31, 2017

Secondary Outcomes

Patient survival

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

Time frame: 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).

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

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.

Time frame: From post-transplantation to Dec 31, 2017

Data from ClinicalTrials.gov

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