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Completed

NCT Number: NCT06044558

Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics

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.

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Key information

Conditions

Kidney Transplant Patients

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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).

Treatment and study plan

Combined with voriconazole

Drug

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

Other names: tacrolimus, methylprednisolone sodium succinate, mycophenolate sodium

Combined with caspofungin

Drug

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

Other names: tacrolimus, methylprednisolone sodium succinate, mycophenolate sodium

Tacrolimus-alone treatment

Drug

Renal transplant patients treated with tacrolimus-based triple immunotherapy alone

Other names: methylprednisolone sodium succinate, mycophenolate sodium

Primary outcomes

  1. The C0/D values of tacrolimus

    Time frame: 2015.01.01-2023.04.01

    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.

Secondary outcomes

  1. The D values of tacrolimus

    Time frame: 2015.01.01-2023.04.01

    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.

Sponsors and collaborators

Lead sponsor

LI YAN

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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