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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Kidney Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute rejection | The incidence of acute rejection within the first 1 year post-transplantation, estimated with Kaplan-Meier survival analysis | 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 | From post-transplantation to Dec 31, 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival | The incidence of death during the follow-up time (number of events or frequency) | 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). | 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. | From post-transplantation to Dec 31, 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tacrolimus, clinical outcomes, genetic polymorphism, clinical factors