UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001773 |
|---|---|
| Receipt number | R000001995 |
| Scientific Title | Prospective Open-labelled Randomized Controlled trial for efficacy of cholesterol lowering intervention in CKD patient with dyslipidemia |
| Date of disclosure of the study information | 2009/03/16 |
| Last modified on | 2013/03/13 11:52:10 |
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Basic information
Public title
Prospective Open-labelled Randomized Controlled trial for efficacy of cholesterol lowering intervention in CKD patient with dyslipidemia
Acronym
RCT for efficacy of cholesterol lowering intervention in CKD with dyslipidemia
Scientific Title
Prospective Open-labelled Randomized Controlled trial for efficacy of cholesterol lowering intervention in CKD patient with dyslipidemia
Scientific Title:Acronym
RCT for efficacy of cholesterol lowering intervention in CKD with dyslipidemia
Region
| Japan |
Condition
Condition
Chronic kidney disease patient with dyslipidemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of cholesterol lowering intervention by pitavastatin vs ezetimib in chronic kidney disease patient with dyslipidemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Urinary protein lowering effect
Improvemant of GFR
Key secondary outcomes
Improvement of inflammation
Improvement of oxdative stress
Improvement of endothelial function
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
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of pitavastatin 1mg. Increase up to 2mg, if LDL lowering effect of pitavastatin is insufficient
Interventions/Control_2
Administration of ezetimibe 10mg. Pravastatin 10mg is add to ezetimibe 10mg, if LDL lowering effect of ezetimibe is insufficient
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
eGFR>15ml/min
urinary protein>0.5g/gcre
LDL>140mg/dl
Key exclusion criteria
End stage renal disease
Severe hapatic damege
Hyper creatine pholphokinase
Inadequate case judged by doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Kobayashi |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Department of Nephrology
Zip code
Address
3-20-1, Amimachicyuo, Inashikigun, Ibaraki, Japan
TEL
029-887-1161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Homara Shimohata, Kouichi Hirayama |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Department of Nephrology
Zip code
Address
3-20-1, Amimachicyuo, Inashikigun, Ibaraki, Japan
TEL
029-887-1161
Homepage URL
h-shimo@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Ibaraki Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 03 | Month | 16 | 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
| 2008 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | 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 | 03 | Month | 13 | Day |
Last modified on
| 2013 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001995
