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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002935
Receipt No. R000003570
Scientific Title A community-based surveillance of ezetimibe added to statin therapy for chronic kidney disease patients.
Date of disclosure of the study information 2010/01/01
Last modified on 2009/12/24

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Basic information
Public title A community-based surveillance of ezetimibe added to statin therapy for chronic kidney disease patients.
Acronym A community-based surveillance of ezetimibe added to statin therapy for chronic kidney disease patients.
Scientific Title A community-based surveillance of ezetimibe added to statin therapy for chronic kidney disease patients.
Scientific Title:Acronym A community-based surveillance of ezetimibe added to statin therapy for chronic kidney disease patients.
Region
Japan

Condition
Condition Chronic kidney disease stage 2-4
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Surveillance of ezetimibe added to statin therapy vs up-titration statin therapy foe CKD.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety Surveillance of ezetimibe added to statin therapy vs up-titration statin therapy
Key secondary outcomes Efficacy Surveillance of ezetimibe added to statin therapy vs up-titration statin therapy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Up-titration statin therapy
Interventions/Control_2 Ezetimibe Added-on statin therapy
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
35 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) CKD stage 2-4
2) LDL-C levels with statin therapy is 120mg/dL or more
3) Aged from 35 years to 75 years
Key exclusion criteria 1 total glyceride less than 400mg dl
2 liver enzyem less than 2 times the upper limit of normal]
3 patients withhomozygous familial hypercholesterolemia
4 patients with homozygous familial hypercholesterolemia
5 within 3 months of study entry of unstable angian, myocardial infarction, surgical coronary intervention or stroke
6 patients who are pregnant or nursing mohters, patients who may be pregnant, or patients who want to become pregnant during participation in the study
7 patients with a hisotry of hypersensitiivity to nay ingredient of ezetimibe tablets
8 other patients deemed not appropriate for study entry by the investigator
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromichi Suzuki
Organization Saitama Medical University
Division name Department of Nephrology
Zip code
Address 38 Morohongo, Moroyama-machi,
TEL 049-276-1612
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiromichi Suzuki
Organization Saitama Medical University
Division name Department of Nephrology
Zip code
Address 38 Morohongo, Moroyama-machi,
TEL 049-276-1620
Homepage URL
Email iromichi@saitama-med.ac.jp

Sponsor
Institute Hiromichi Suzuki
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 埼玉医科大学病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 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
2009 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 24 Day
Last modified on
2009 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003570

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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