臨床研究等提出・公開システム

Date of registration	May. 25, 2022
Last modified on	April. 02, 2025
Trial ID	jRCTs041220021

Scientific Title	An Exploratory Study to Evaluate the Efficacy and Safety of a Cisplatin Metabolism-Related Enzyme Inhibitor in Cisplatin-Induced Nephrotoxicity
Public Title	Clinical Trial for Prevention of Cisplatin-Induced Renal Nephrotoxicity

Contact for Scientific Queries	Name	Kondo Masashi
	Affiliation	Fujita Health University Hospital
	Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
	Telephone	+81-562-93-9409
	E-mail	mkond@fujita-hu.ac.jp
Contact for Public Queries	Name	Koseki Takenao
	Affiliation	Fujita Health University
	Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
	Telephone	+81-562-93-9563
	E-mail	tkoseki@fujita-hu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 25, 2022
Actual date of first enrollment		July. 30, 2024
Target sample size		21
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Has provided written consent for participation - Age 18 or greater at the time of consent - Has never received cisplatin-containing chemotherapy - Scheduled for chemotherapy with cisplatin only or cisplatin plus other one- or two- anticancer agents under hospitalization - Lung, head and neck, and other cancer patients scheduled for cisplatin regimens with doses of 75 mg/m2 or higher in patients with
	Exclusion Criteria	- Presence of renal dysfunction: eGFR<60 mL/min/1.73 m2 - Pregnant or possibly pregnant women - Lactating women - With a history of hypersensitivity to flopropione - Deemed ineligible for the study as determined by the principal investigator or a co-investigator
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cancer
Intervention(s)		flopropione dosing
Primary Outcome(s)		Occurrence of adverse events
Secondary Outcome(s)		Changes in cisplatin-induced nephrotoxicity markers

Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Fujita Health University Certified Review Board
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Telephone	+81-562-93-2865
E-Mail	crb-f@fujita-hu.ac.jp
Approval Status	Approval
Date of approval	April. 27, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
9	April. 02, 2025	(this page)	Changes
8	Sept. 27, 2024	Detail	Changes
7	July. 30, 2024	Detail	Changes
6	July. 01, 2024	Detail	Changes
5	July. 01, 2024	Detail	Changes
4	June. 26, 2024	Detail	Changes
3	June. 04, 2024	Detail	Changes
2	Sept. 09, 2022	Detail	Changes
1	May. 25, 2022	Detail

List of change history