UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial to examine the influence to vascular endothelium function to treat of anemia in the heart disease patients with chronic kidney disease.
Title of the study (Brief title)	Impact on vascular endothelium function to treat of anemia in the heart disease patients with chronic kidney disease.
Region	Japan

Condition
Condition	Chronic heart disease,Coronary artery disease, Chronic kidni disease, anemia
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	I examine safety of epoetin beta pegol for heart disease patients complicated with renal anemia , and influence on vascular endotherium function and cardiac function.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Vascular endotherium function
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	epoetin beta pegol
Interventions/Control_2	iron drug
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	CKD eGFR<60 8<Hb<11 NYHA 2,3 stable coronary artery disease
Key exclusion criteria	HD Anemia without renal anemia Bleeding Malignancy Iron deficiency anemia
Target sample size	40

Research contact person
Name of lead principal investigator	Hisao Ogawa
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Address	1-1-1, Honjo, Chuo-ku, Kumamoto City
TEL	096-373-5175
Email	cvmhisho@kumamoto-u.ac.jp

Public contact
Name of contact person	Seiji Hokimoto
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Address	1-1-1, Honjo, Chuo-ku, Kumamoto City
TEL	096-373-5175
Homepage URL
Email	shokimot@kumamoto-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization	The Ministry of Education, Science, and Culture in Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2014 Year 07 Month 07 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 07 Month 01 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 07 Month 07 Day
Last modified on	2019 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016729