Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics

Kidney Transplant Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06044558
• Other study ID #: QFS-LY-2023-TAC-001
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: June 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Kidney Transplant Patients

Intervention

Drug:
• Combined with voriconazole
Renal transplant patients taking tacrolimus-based triple immunotherapy and voriconazole drug combination.
• Combined with caspofungin
Renal transplant patients taking a combination of tacrolimus-based triple immunotherapy and caspofungin drugs.
• Tacrolimus-alone treatment
Renal transplant patients treated with tacrolimus-based triple immunotherapy alone

Locations

Country	Name	City	State
China	Shandong Provincial Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
LI YAN

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2015.01.01-2023.04.01
Secondary	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.	2015.01.01-2023.04.01