UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of AST-120 on chronic kidney disease with stable angina: randomized controlled open-labeled trial
Title of the study (Brief title)	The efficacy of AST-120 on chronic kidney disease with stable angina
Region	Japan

Condition
Condition	Ischemic heart disease Chronic kidney disease
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of AST-120 to carotid intima thickness and the vascular endothelial function in patients with coronary artery disease comorbid with chronic kidney disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of change of carotid intima-media thickness The amount of change of vascular endothelial function
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	AST-120
Interventions/Control_2	control
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	stable angina eGFR 15-45ml/min/1.732
Key exclusion criteria	patients with pregnancy
Target sample size	50

Research contact person
Name of lead principal investigator	Toyoaki Murohara
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Cardiology
Address	65, Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL	052-744-2150
Email	murohara@med.nagoya-u.ac.jp

Public contact
Name of contact person	Susumu Suzuki
Organization	Nagoya University Graduate School of Medicine
Division name	Department of CKD Initiatives Internal Medicine
Address	65, Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL	052-744-2202
Homepage URL
Email	susumusuzuki@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Cardiology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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	名古屋大学病院(愛知県)

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

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

Management information
Registered date	2014 Year 10 Month 12 Day
Last modified on	2018 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017921