臨床研究等提出・公開システム

Date of registration	Dec. 17, 2021
Last modified on	July. 26, 2024
Trial ID	jRCT2041210113

Scientific Title	General drug use-results survey of UPASITA IV Injection Syringe for Dialysis
Public Title	General drug use-results survey of UPASITA IV Injection Syringe for Dialysis

Contact for Scientific Queries	Name	Dept. Pharmacovigilance
	Affiliation	Sanwa Kagaku Kenkyusho Co., Ltd.
	Address	35,Higashisotoboricho, Higashi-ku,Nagoya, Aichi
	Telephone	+81-52-951-8167
	E-mail	pms@ml.skk-net.com
Contact for Public Queries	Name	Dept. Pharmacovigilance
	Affiliation	Sanwa Kagaku Kenkyusho Co., Ltd.
	Address	35,Higashisotoboricho, Higashi-ku,Nagoya, Aichi
	Telephone	+81-52-951-8167
	E-mail	pms@ml.skk-net.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 20, 2022
Actual date of first enrollment		Feb. 21, 2022
Target sample size		770
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with secondary hyperparathyroidism under hemodialysis who are using this drug for the first time
	Exclusion Criteria	None
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Secondary hyperparathyroidism under hemodialysis
Primary Outcome(s)		Incidence of onset of hypocalcaemia Incidence of onset of QT prolonged Incidence of onset of bone metabolism disorder

Primary Sponsor	Sanwa Kagaku Kenkyusho Co., Ltd.

Secondary Sponsor

Name of Certified Review Board	Not Applicable due to Observational Study
Address	-, Aichi

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	July. 26, 2024	(this page)	Changes
2	Feb. 02, 2022	Detail	Changes
1	Dec. 17, 2021	Detail

List of change history