UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001774 |
|---|---|
| Receipt number | R000002044 |
| Scientific Title | A controlled ,Prospective Study of the Effects of statins on Progression of diabetic nephropathy |
| Date of disclosure of the study information | 2009/03/14 |
| Last modified on | 2014/09/14 19:28:36 |
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Basic information
Public title
A controlled ,Prospective Study of the Effects of statins on Progression of diabetic nephropathy
Acronym
A controlled ,Prospective Study of the Effects of statins on Progression of diabetic nephropathy
Scientific Title
A controlled ,Prospective Study of the Effects of statins on Progression of diabetic nephropathy
Scientific Title:Acronym
A controlled ,Prospective Study of the Effects of statins on Progression of diabetic nephropathy
Region
| Japan |
Condition
Condition
diabetic nephropathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study of effect of statins on Patients with Early Diabetic Nephropathy and A controlled ,Prospective Study of the Effects of statins on Progression of diabetic nephropathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Prospective Study of the Effects of
Cholesterol-lowering therapy in Between
3 group ( diet therapy group, standard therapies group (pravastatin 10mg), iactive treatment group(atorvastatin10mg )
on Progression of diabetic nephropathy.
Key secondary outcomes
1)Nephropathic analysis in before and after about chemical administration
2)Analysis of LDL-C in before and after about this chemical administration
3)Comparison in diet therapy,atorvastatin,pravastatin in superscription
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
diet therapy group
Interventions/Control_2
standard therapies group
(pravastatin 10mg)
Interventions/Control_3
active treatment group
(atorvastatin 10mg)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Age is 18 years old-80 years old, and sexuality is no object
2 A minor or middle-class nephropathic definition:following conditions more than once at the same time
1) serum creatinine concentration 0.9-1.5mg/dl
2) urinary albumin positive or urine protein (qualitative analysis) is more than +-
3 Calculation method of LDL-C value:
It depends on either of Freidwald method (equal to or less than TG 400mg/dl)or direct technique
4 The case that an agreement in a document is obtained than the person himself in becoming a subject of the final examination.
Key exclusion criteria
1 While person take statins, or statins administration is done one within three months
2 160/100mm Hg is more than most recent twice sphygmomanometry value together the one where blood pressure control is poor
3 Drifting for three months is higher than 2% more than most recent HbA1c10% recently the one where glycemic control states are defectiveness or insecurity
4 The one that presents nephrotic syndrome
5 The person who judged that others, a family doctor were inadequate
6 Others, Dr.clinical study liability or Dr.clinical study allotment is this clinical study which they intend for it and judged to be inadequate
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takazakura Akiko |
Organization
endocrine and metabolic internal medicine
Division name
internal medicine
Zip code
Address
7-1,FUNABASHI,WADANAKA-CHO,FUKUI,918-8503,Japan
TEL
0776-23-1111
sakura197693@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takazakura Akiko |
Organization
Fukuiken-Saiseikai Hospital
Division name
internal medicine
Zip code
Address
7-1,FUNABASHI,WADANAKA-CHO,FUKUI,918-8503,Japan
TEL
0776-23-1111
Homepage URL
sakura197693@gmail.com
Sponsor or person
Institute
Fukuiken-Saiseikai Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuiken-Saiseikai Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kanazawa University School of Medicine Hospital
Name of secondary funder(s)
Kanazawa University School of Medicine Hospital
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 | 14 | 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
Completed
Date of protocol fixation
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 14 | Day |
Last modified on
| 2014 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002044
