UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014497
Receipt No. R000016729
Scientific Title Randomized controlled trial to examine the influence to vascular endothelium function to treat of anemia in the heart disease patients with chronic kidney disease.
Date of disclosure of the study information 2014/07/07
Last modified on 2019/01/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized controlled trial to examine the influence to vascular endothelium function to treat of anemia in the heart disease patients with chronic kidney disease.
Acronym Impact on vascular endothelium function to treat of anemia in the heart disease patients with chronic kidney disease.
Scientific Title Randomized controlled trial to examine the influence to vascular endothelium function to treat of anemia in the heart disease patients with chronic kidney disease.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisao Ogawa
Organization Graduate School of Medical Sciences,
Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
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
1st name
Middle name
Last name Seiji Hokimoto
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2014 Year 07 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000016729

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.