Impact of CYP3A5 polymorphisms on intra-patient variability of tacrolimus pharmacokinetics in kidney transplant recipients

Not Applicable

• Conditions: age over 18 years old, received immunosuppressive therapy based on twice- daily tacrolimus (Prograf®); tacrolimus; pharmacokinetics; intrapatient variability; CYP3A5

• Registration Number: TCTR20180619003
• Lead Sponsor: Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-19
• Study Completion: 2018-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1) age over 18 years old
2) immunosuppressive therapy based on twice-daily tacrolimus (Prograf®)
3) graft survival for at least 6 months after transplantation.

Exclusion Criteria

1) were multiorgan transplanted
2) died or graft lost for any reason before study begins
3) had history of active liver disease during 6 and 12 months after transplantation such as cirrhosis, viral hepatitis or hepatocellular carcinoma
4) received any medications that can interfere tacrolimus pharmacokinetics, with the exception of PPI drug group
5) had history of medication noncompliance in patient record
6) data did not complete.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intra-patient variability (IPV) of tacrolimus concentration to dose ratio (C/D) after transplantation CMIA

Secondary Outcome Measures

Name	Time	Method
tacrolimus concentration to dose ratio (C/D) after transplantation CMIA