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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002528
Receipt No. R000003088
Scientific Title Therapeutic effects of cholesterol absorption inhibitor on renal function in patients with chronic kidney disease
Date of disclosure of the study information 2009/09/18
Last modified on 2015/09/19

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Basic information
Public title Therapeutic effects of cholesterol absorption inhibitor on renal function in patients with chronic kidney disease
Acronym Therapeutic effects of cholesterol absorption inhibitor on renal function in patients with chronic kidney disease
Scientific Title Therapeutic effects of cholesterol absorption inhibitor on renal function in patients with chronic kidney disease
Scientific Title:Acronym Therapeutic effects of cholesterol absorption inhibitor on renal function in patients with chronic kidney disease
Region
Japan

Condition
Condition Chronic kidney disease
Hypercholesterolemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the therapeutic effects and safety aspects of Ezetimibe, a Niemann Pick C1-like1 inhibitor which inhibits cholesterol absorption, in patients with chronic kidney disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1) Lipid profile including T-cho, LDL-C, HDL-C, TG, and RLP-C.
2) eFGR
3) Urinary albumin excretion
Key secondary outcomes 1) Glucose profile including FPG, HbA1C, and IRI.
2) Markers of cholesterol synthesis and absorption
3) Markers of oxidative stress including pentosidine and L-FABP
4) CBC and biochemistry including AST, ALT, gammaGTP, BUN, sCr, K, BNP
5) Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ezetimib 10 mg once daily is administerd as a additive medicine for lipid-lowering therapy.
Interventions/Control_2
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 Chronic kidney disease
LDL-C > or= 120mg/dl
Key exclusion criteria 1. History of hypersensitivity to ezechimibe
2. Dialysis patients
3. Severe liver disease
4. Secondary or drug-induced hypercholesterolemia
5. Pregnant or nursing women or women suspect of pregnancy
6. Judged as inappropriate for study by doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouichi TAMURA
Organization Yokohama City University School of Medicine
Division name Department of Cardiorenal Medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL 045-787-2635
Email tamukou@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouichi Tamura
Organization Yokohama City University School of Medicine
Division name Department of Cardiorenal Medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL 045-787-2635
Homepage URL
Email tamukou@med.yokohama-cu.ac.jp

Sponsor
Institute Department of Medical Science and Cardiorenal Medicine,
Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Medical Science and Cardiorenal Medicine,
Yokohama City University Graduate School of Medicine
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 横浜市立大学附属病院
Yokohama City University Hospital

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 18 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 Terminated
Date of protocol fixation
2009 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2014 Year 08 Month 01 Day
Date of closure to data entry
2015 Year 08 Month 01 Day
Date trial data considered complete
2016 Year 09 Month 01 Day
Date analysis concluded
2017 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 18 Day
Last modified on
2015 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003088

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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