Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics

LI YAN507 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

507

Conditions

Kidney Transplant Patients

Interventions

Combined with voriconazoleDRUG

Renal transplant patients taking tacrolimus-based triple immunotherapy and voriconazole drug combination.

Combined with caspofunginDRUG

Renal transplant patients taking a combination of tacrolimus-based triple immunotherapy and caspofungin drugs.

Tacrolimus-alone treatmentDRUG

Renal transplant patients treated with tacrolimus-based triple immunotherapy alone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with first kidney transplantation and intact CYP3A5 genotype; 2. Renal transplant recipients taking a tacrolimus-based triple immunosuppressive regimen (tacrolimus + sodium mescaline enteric-coated tablets + glucocorticoids) postoperatively; 3. Age ≥ 18 years. Exclusion Criteria: 1. Missing and incomplete clinical information and postoperative follow-up data; 2. Multi-organ combined transplantation and secondary transplantation; 3. Postoperative simultaneous joint application of other drugs that affect the blood concentration of tacrolimus or voriconazole or caspofungin (e.g. pentoxifylline capsules, rifampicin, etc.); 4. Severe impairment of liver function or severe gastrointestinal diseases, gastrointestinal resection surgery, malabsorption syndrome; 5. Pregnant and lactating women; 6. Recipients with significant rejection of the transplanted organ or death due to other reasons within 1\~2 months after surgery; 7. Poor compliance and accuracy of results (e.g., irregular blood collection times).

Locations (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Outcomes

Primary Outcomes

The C0/D values of tacrolimus

Body weight is in kilograms, D values are in mg/d, and the combination of body weight and D is the body weight-corrected D value in mg/kg/d, with a range of 0.15-0.30 mg/kg/d. The C0 for tacrolimus is in ng/ml, with a range of 5-15 ng/ml, and the combination of the C0 and body weight-corrected D values is the C0/D value, reported as (ng/ml)/(mg /kg/d) is reported.

Time frame: 2015.01.01-2023.04.01

Secondary Outcomes

The D values of tacrolimus

Body weight was expressed in kilograms, D values were expressed in mg/d, and body weight and D were combined to give body weight-corrected D values in mg/kg/d, ranging from 0.15 to 0.30 mg/kg/d.

Time frame: 2015.01.01-2023.04.01

Data from ClinicalTrials.gov

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