Population pharmacokinetic study of the interaction between tacrolimus and triazole antifungals in liver transplant patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100053549

Enrollment

Unknown

Registered

2021-11-24

Start date

2022-01-01

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

None listed

Interventions

Combined voriconazole group:None

Combined posaconazole group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged > 18 years; 2. The first liver transplantation, no other organ transplantation experience, the donor is from a donor who died of cardiac death (DCD); 3. Continuous oral tacrolimus, during which the drug was not discontinued due to rejection or other reasons; 4. Use voriconazole or posaconazole to prevent or treat fungal infections; 5. Those who can fully understand the purpose of this study and understand possible adverse reactions, voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with poor compliance; 2. Patients with severe renal insufficiency (creatinine clearance <15 mL/min) or patients undergoing plasma purification, hemodialysis or peritoneal dialysis during hospitalization; 3. Patients with acute and chronic digestive system ulcers and severe gastrointestinal diseases; 4. Patients who have used other drugs that may have significant interaction with tacrolimus (such as five ester capsules, mycophenolate mofetil, etc.).

Design outcomes

Primary

Measure	Time frame
Drug concentration;	—

Countries

China

Contacts

Public ContactQiu Xiaoyan

xyqiu@fudan.edu.cn+86 13585826324

Outcome results