UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007897
Receipt No. R000008947
Scientific Title Effects of oral small spherical activated charcoal (Kremezin) on inflammatory cytokines and coronary plaque component assessed by integrated backscatter intravascular ultrasound
Date of disclosure of the study information 2012/06/01
Last modified on 2012/12/25

* 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 Effects of oral small spherical activated charcoal (Kremezin) on inflammatory cytokines and coronary plaque component assessed by integrated backscatter intravascular ultrasound
Acronym Antiarteriosclerotic effect of oral small spherical activated charcoal (Kremezin)
Scientific Title Effects of oral small spherical activated charcoal (Kremezin) on inflammatory cytokines and coronary plaque component assessed by integrated backscatter intravascular ultrasound
Scientific Title:Acronym Antiarteriosclerotic effect of oral small spherical activated charcoal (Kremezin)
Region
Japan

Condition
Condition chronic renal failure patients( eGFRis less than 45 ml/min/1.73m2)
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to examine effects of Kremezin on inflammatory cytokines and coronary plaque component assessed by integrated backscatter intravascular ultrasound
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes tissue characterization of coronary plaque

levels of inflammatory cytokine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1)Tissue characteristics of coronary plaques and levels of inflammatory cytokines were examined
2) Kremezin was added
3)Tissue characteristics of the same coronary plaques and levels of inflammatory cytokines were examined 6 months after first IB-IVUS examination
Interventions/Control_2 1)Tissue characteristics of coronary plaques and levels of inflammatory cytokines were examined
2)no additional drugs were added
3)Tissue characteristics of the same coronary plaques and levels of inflammatory cytokines were examined 6 months after first IB-IVUS examination
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients with stable angina planned to be treated with stent
2)Chronic renal failure patients (eGFR<45ml/min/1.73m2)
3)Patients who had been treated with statin(LDL-cho< 100mg/dl)
4)written informed consent before the
Key exclusion criteria 1)Dialysis patients
2)Patients with cancer
3)Patients with a history of coronary artery bypass surgery
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masataka Sata
Organization Tokushima university hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 2-50-1 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokushima university hospital
Division name Division of cardiology
Zip code
Address
TEL
Homepage URL
Email yamakoji3@hotmail.com

Sponsor
Institute Tokushima university hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2012 Year 06 Month 01 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 Open public recruiting
Date of protocol fixation
2012 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 05 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
2012 Year 05 Month 07 Day
Last modified on
2012 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008947

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.