UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021583 |
|---|---|
| Receipt number | R000024891 |
| Scientific Title | Evaluation of the effect of rosuvastatin on renoprotective effect |
| Date of disclosure of the study information | 2016/03/25 |
| Last modified on | 2020/04/02 09:16:44 |
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Basic information
Public title
Evaluation of the effect of rosuvastatin on renoprotective effect
Acronym
Rosuvastatin-kidney study
Scientific Title
Evaluation of the effect of rosuvastatin on renoprotective effect
Scientific Title:Acronym
Rosuvastatin-kidney study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluaton of the protective effect of rosuvastatin on the diabetic podocyte injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of urinary nephrin excretion after 6 months
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Once daily 2.5 mg of Rosuvastatin is administerd during 6 months
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
Patient with hyperchoresterolemia
Patients whose urinary albumin secretion is below 300 mg/gCr
Key exclusion criteria
Patient is started or changed renin angiotensin system inhibitor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Makino |
| Middle name | |
| Last name | Hisashi |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Atherosclerosis and Diabetes
Zip code
565-0873
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
makinoh@hsp.ncvc.go.jp
Public contact
Name of contact person
| 1st name | Makino |
| Middle name | |
| Last name | Hisashi |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Atherosclerosis and Diabetes
Zip code
565-0873
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
Homepage URL
makinoh@hsp.ncvc.go.jp
Sponsor or person
Institute
Rosuvastatin-kidney study group
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
Tel
06-6833-5012
makinoh@ncvc.go.jp
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 | 25 | 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
| 2014 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 23 | Day |
Last modified on
| 2020 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024891
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
