臨床研究等提出・公開システム

Date of registration	Jan. 07, 2022
Last modified on	Nov. 28, 2025
Trial ID	jRCT2031210549

Scientific Title	Special use-results survey of ENAROY Tablets (long-term use)
Public Title	Special use-results survey of ENAROY Tablets (long-term use)

Contact for Scientific Queries	Name	Patient Safety and Pharmacovigilance Dept.
	Affiliation	Shionogi & Co., Ltd.
	Address	3-4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo, Japan
	Telephone	+81-80-1054-2168
	E-mail	DL_pms-pharma@shionogi.co.jp
Contact for Public Queries	Name	Patient Safety and Pharmacovigilance Dept.
	Affiliation	Shionogi & Co., Ltd.
	Address	3-4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo, Japan
	Telephone	+81-80-1054-2168
	E-mail	DL_pms-pharma@shionogi.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Feb. 07, 2022
Actual date of first enrollment		Mar. 04, 2022
Target sample size		1500
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients using Enaroy for the first time for nephrogenic anemia (2) Patients must provide informed consent before the start
	Exclusion Criteria	none
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Anemia associated with CKD
Primary Outcome(s)		-Incidence of onset of thromboembolism -Incidence of onset of hypertension -Incidence of cardiovascular events (excluding thromboembolism) -Incidence of onset of retinal hemorrhage -Incidence of onset of malignant tumor -Incidence of progressed disease in patients with autosomal dominant polycystic kidney disease (ADPKD)

Primary Sponsor	Shionogi & Co., Ltd.

Name of Certified Review Board	None
Address	None, Tokyo

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	Nov. 28, 2025	(this page)	Changes
5	Mar. 07, 2025	Detail	Changes
4	Oct. 19, 2023	Detail	Changes
3	April. 07, 2023	Detail	Changes
2	Feb. 15, 2022	Detail	Changes
1	Jan. 07, 2022	Detail

List of change history