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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001724
Receipt No. R000002076
Scientific Title A controlled ,Prospective Study of the Effects of statins on Progression of diabetic nephropathy
Date of disclosure of the study information 2009/02/22
Last modified on 2014/08/24

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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 -participants 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
Email sakura197693@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takazakura Akiko
Organization Internal secretion metabolism internal medicine
Division name internal medicine
Zip code
Address 7-1,FUNABASHI,WADANAKA-CHO,FUKUI,918-8503,Japan
TEL 0776-23-1111
Homepage URL
Email sakura197693@gmail.com

Sponsor
Institute Fukuiken-Saiseikai Hospital
Institute
Department

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
Email

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 02 Month 22 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
2013 Year 10 Month 01 Day
Date of closure to data entry
2013 Year 10 Month 01 Day
Date trial data considered complete
2013 Year 10 Month 01 Day
Date analysis concluded
2013 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 02 Month 22 Day
Last modified on
2014 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002076

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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