The Influence of Genetic and Clinical Factors on Clinical Outcomes of Kidney Transplant Patients With Tacrolimus Based Immunosuppression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Kidney Transplantation
- Sponsor
- National Taiwan University Hospital
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Acute rejection
- Status
- Completed
- Last Updated
- 5 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Kidney function measured by estimated glomerular filtration rate (eGFR)(From post-transplantation to Dec 31, 2017)
- Incidence of adverse events, including post-transplant diabetes mellitus, deterioration of liver function, cancer, infection and hyperlipidemia(From post-transplantation to Dec 31, 2017)
- Patient survival(From post-transplantation to Dec 31, 2017)