臨床研究等提出・公開システム

Date of registration	Oct. 31, 2025
Last modified on	Oct. 31, 2025
Trial ID	jRCT1070250090

Scientific Title	Evaluation of Hepatic and Renal Function Algorithms for Fosravuconazole in Real-world Clinical Practice
Public Title	Evaluation of Hepatic and Renal Function Algorithms for Fosravuconazole

Contact for Scientific Queries	Name	Harunari Shimoyama
	Affiliation	Mizonokuchi dermatology and Medical Mycology Clinic
	Address	4F, Mizonokuchi Flower Medical Mall, 2-2-8 Shimosakunobe, Takatsu-ku, Kawasaki-shi, Kanagawa
	Telephone	+81-44-982-3111
	E-mail	harunarishimoyama@med.teikyo-u.ac.jp
Contact for Public Queries	Name	Harunari Shimoyama
	Affiliation	Mizonokuchi dermatology and Medical Mycology Clinic
	Address	4F, Mizonokuchi Flower Medical Mall, 2-2-8 Shimosakunobe, Takatsu-ku, Kawasaki-shi, Kanagawa
	Telephone	+81-44-982-3111
	E-mail	harunarishimoyama@med.teikyo-u.ac.jp

Recruitment status	Not Recruiting

Study Design
Anticipated date of first enrollment		Nov. 01, 2025
Target sample size		130
Study Type		Observational



	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	patients diagnosed with onychomycosis by direct microscopy, treated with fosravuconazole between 20 March 2023 and 31 July 2025, and who underwent two laboratory tests: baseline and follow-up, during treatment.
	Exclusion Criteria	none
	Age Minimum	No limit
	Age Maximum	No limit

Health Condition(s) or Problem(s) Studied		Onychomycosis
Health Condition(s) Code		D014009
Primary Outcome(s)		AST, ALT,GGT, SCr, and eGFR
Secondary Outcome(s)		Fold-change values of AST, ALT, GGt, SCr, and eGFR

Primary Sponsor	none

Name of Certified Review Board	Noguchi Dermatology Ethics Committee
Address	964-1 Kami-jima, Kashima-machi, Kamimashiki-gun, Kumamoto, Kumamoto
Telephone	+81-96-237-4112
Approval Status	Approval
Date of approval	Oct. 31, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none