Status:
COMPLETED
Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics
Lead Sponsor:
LI YAN
Conditions:
Kidney Transplant Patients
Eligibility:
All Genders
18-80 years
Brief Summary
The purpose of this observational study is to analyze the extent and characteristics of drug interactions (focusing on azole antifungals and echinocandins) and genetic polymorphisms on tacrolimus bloo...
Detailed Description
In this study, investigators investigated the effects of CYP3A5 and CYP2C19 gene polymorphisms on the trough concentration of tacrolimus after renal transplantation in recipients who were on a tacroli...
Eligibility Criteria
Inclusion
- Patients with first kidney transplantation and intact CYP3A5 genotype;
- Renal transplant recipients taking a tacrolimus-based triple immunosuppressive regimen (tacrolimus + sodium mescaline enteric-coated tablets + glucocorticoids) postoperatively;
- Age ≥ 18 years.
Exclusion
- Missing and incomplete clinical information and postoperative follow-up data;
- Multi-organ combined transplantation and secondary transplantation;
- Postoperative simultaneous joint application of other drugs that affect the blood concentration of tacrolimus or voriconazole or caspofungin (e.g. pentoxifylline capsules, rifampicin, etc.);
- Severe impairment of liver function or severe gastrointestinal diseases, gastrointestinal resection surgery, malabsorption syndrome;
- Pregnant and lactating women;
- Recipients with significant rejection of the transplanted organ or death due to other reasons within 1\~2 months after surgery;
- Poor compliance and accuracy of results (e.g., irregular blood collection times).
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
507 Patients enrolled
Trial Details
Trial ID
NCT06044558
Start Date
September 1 2022
End Date
June 1 2023
Last Update
September 28 2023
Active Locations (1)
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1
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China