臨床研究等提出・公開システム

Date of registration	Nov. 29, 2022
Last modified on	Sept. 03, 2024
Trial ID	jRCT2032220478

Scientific Title	A multicenter controlled trial of NP029 in patients with dialysis shunt insufficiency
Public Title	A multicenter controlled trial of NP029 in patients with dialysis shunt insufficiency

Contact for Scientific Queries	Name	shima yasuhiro
	Affiliation	Nipro Corporation
	Address	7-3-1 Hongo, Bunkyo-ku, Tokyo National University Corporation University of Tokyo Hospital Inpatient Building B 13th Floor, Nipro Research and Development Center, University of Tokyo
	Telephone	+81-3-3868-5033
	E-mail	shima-yasuhiro@nipro.co.jp
Contact for Public Queries	Name	shima yasuhiro
	Affiliation	Nipro Corporation
	Address	7-3-1 Hongo, Bunkyo-ku, Tokyo National University Corporation University of Tokyo Hospital Inpatient Building B 13th Floor, Nipro Research and Development Center, University of Tokyo
	Telephone	+81-3-3868-5033
	E-mail	shima-yasuhiro@nipro.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		May. 01, 2022
Actual date of first enrollment		July. 13, 2022
Target sample size		130
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients aged >=20 years at the time of consent, etc.
	Exclusion Criteria	Patients who are judged by the investigator or subinvestigator to be unsuitable to participate in the study, etc.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		dialysis shunt failure
Intervention(s)		Randomization is performed for lesions with successful predilation. Subjects assigned to the test device (NP029) will apply the drug at NP029. Up to 3 NP029 balloons can be used up to a total length of 180 mm. Subjects assigned to the control device will undergo additional dilation with a general PTA balloon catheter.
Primary Outcome(s)		Primary patency rate of target lesions up to 6 months after investigational procedure

Primary Sponsor	Nipro Corporation

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-5123-0028
E-Mail	soudan@hurecs.org
Approval Status	Approval
Date of approval	June. 03, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Sept. 03, 2024	(this page)	Changes
2	July. 04, 2023	Detail	Changes
1	Nov. 29, 2022	Detail

List of change history