UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021356 |
|---|---|
| Receipt number | R000024629 |
| Scientific Title | The effecs of intensive lipid-lowering therapy on the progression of atherosclerotic kidney disease |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2016/03/05 04:09:02 |
* 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
The effecs of intensive lipid-lowering therapy on the progression of atherosclerotic kidney disease
Acronym
Lipid-lowering therapy for CKD
Scientific Title
The effecs of intensive lipid-lowering therapy on the progression of atherosclerotic kidney disease
Scientific Title:Acronym
Lipid-lowering therapy for CKD
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the clinical effects by lipid-lowering therapy with statins on the renal blood flow measured by renal doppler ultrasoud technique
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Parameters of the ultrasound doppler technique
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
5mg of robuvastatin
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
Normotensive patients with chronic kidney disease
Key exclusion criteria
patients with diabetes
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shu Wakino |
Organization
Keio University, School of Medicine
Division name
Division of Nephrology, Endocrinology, and Diabetes
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
shuwakino@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shu Wakino |
Organization
Keio University, School of Medicine
Division name
Division of Nephrology, Endocrinology, and Diabetes
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
shuwakino@z8.keio.jp
Sponsor or person
Institute
University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
health insurance
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
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
| 2016 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 05 | Day |
Last modified on
| 2016 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024629
