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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

TCTR

Registry ID

TCTR20180619003

Enrollment

200

Registered

2018-06-19

Start date

2018-06-18

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

age over 18 years old&#44

Interventions

stable kidney transplant recipients

Screening

kidney transplant recipients

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
tacrolimus concentration to dose ratio (C/D) after transplantation CMIA	—

Countries

Thailand

Contacts

Public ContactAlmas NUchjumroon

Faculty of Pharamceutical Sciences, Chulalongkorn University

masmello19@gmail.com66865440674

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

Impact of CYP3A5 polymorphisms on intra&#45;patient variability of tacrolimus pharmacokinetics in kidney transplant recipients