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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764670
• Other study ID #: 201809018RINB
• Status: Completed
• Start date: November 30, 2018
• Est. completion date: September 22, 2020

Study information

• Verified date: September 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 22, 2020
• Est. primary completion date: October 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patient survival	The incidence of death during the follow-up time (number of events or frequency)	From post-transplantation to Dec 31, 2017
Secondary	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
Secondary	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