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

Completed

• Conditions: Kidney Transplantation

• Registration Number: NCT03764670
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2018-11-15
• Study Start: 2018-11-30
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-05
• Primary Completion: 2019-10-03
• Status Verified: 2020-09
• Study Completion: 2020-09-22
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1. Kidney transplantation
2. 20-65 years old
3. Receiving tacrolimus-based immunosuppressants
4. Were recruited in a previous trial

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Exclusion Criteria

1. Human immunodeficiency virus-positive status
2. Retransplantation or multiorgan transplantation
3. Non-Asian

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan