UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002528 |
|---|---|
| Receipt number | 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 10:03:48 |
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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
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
tamukou@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine,
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003088
