NCT06044558

Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics

Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics in Kidney Transplant Recipients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 507 (actual)
• Sponsor: LI YAN · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 blood concentrations in renal transplant recipients in order to provide a reference for the appropriate adjustment of tacrolimus dosing regimen to reduce the incidence of adverse drug reactions and rejection, and to improve the survival of transplanted kidneys.

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 tacrolimus-based immunosuppressive regimen (tacrolimus + mescaline + glucocorticosteroid) after their first renal transplantation; investigators investigated the effects of antifungal drugs on the trough concentration of tacrolimus, and investigators also analyzed the effects of genetic factors on the drug-drug interactions between antifungal drugs and tacrolimus, with the aim of providing a basis of reference for the rational use of tacrolimus and antifungal drugs in the clinic.

Conditions

• Kidney Transplant Patients

Interventions

Type	Name	Description
DRUG	Combined with voriconazole	Renal transplant patients taking tacrolimus-based triple immunotherapy and voriconazole drug combination.
DRUG	Combined with caspofungin	Renal transplant patients taking a combination of tacrolimus-based triple immunotherapy and caspofungin drugs.
DRUG	Tacrolimus-alone treatment	Renal transplant patients treated with tacrolimus-based triple immunotherapy alone

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-01-01
• Completion: 2023-06-01
• First posted: 2023-09-21
• Last updated: 2023-09-28

Locations

1 site across 1 country: China