UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	RenalGuard System to Prevent Contrast-Induced Acute Kidney Injury in Japan
Title of the study (Brief title)	RESPECT KIDNEY
Region	Japan

Condition
Condition	Chronic kidney disease with coronary aretry disease or peripheral artery disease
Classification by specialty	Medicine in general Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of RenalGuard System in the prevention of contrast-induced nephropathy in the setting of a catheterization laboratory
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Combined incidence of contrast-induced nephropathy (CIN) and serious in-hospital therapy-related adverse events
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	RenalGuard group
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Male or non-pregnant female equal or greater than the age 20 years old and is able to provide informed consent. Subject is scheduled to undergo an catheterization procedure that is expected to use at least 75 ml of intraarterial contrast. Subject has moderate to severe kidney impairement-eGFR<45 ml/min/1.73m2 and more than 30 % of ejection fraction of left ventricle.
Key exclusion criteria	Class 3 or 4 chronic heart failure. Subject is anuric or has undergone renal replacement therapy, or has a known inability to have a Foley catheter placed. Subject has received contrast within 7 days of procedure. Subject has a known hypersensitivity to furosemide and/or the contrast agent being used.
Target sample size	60

Research contact person
Name of lead principal investigator	Ichiro Michishita
Organization	Federation of National Public Service Personnel Mutual Aid Associations, Yokohama Sakae Kyosai Hospital
Division name	Division of Cardiology, Department of Internal Medicine
Address	132 Katura-cho, Sakae-ku, Yokohama-shi
TEL	045-891-2171
Email	i-michishita@yokohamasakae.jp

Public contact
Name of contact person	Tsuyoshi Nozue
Organization	Yokohama Sakae Kyosai Hospital
Division name	Divison of Cardiology, Department of Internal Medicine
Address	132 Katsura-cho, Sakae-ku, Yokohama-shi
TEL	045-891-2171
Homepage URL
Email	nozue2493@yahoo.co.jp

Sponsor
Institute	Yokohama Sakae Kyosai Hospital
Institute
Department

Funding Source
Organization	Yokohama Sakae Kyosai Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 02 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 01 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 09 Month 30 Day
Date trial data considered complete	2016 Year 09 Month 30 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 02 Month 16 Day
Last modified on	2018 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008616