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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000361
Receipt No. R000000461
Scientific Title Effect of simvastatin for chronic glomerulonephritis
Date of disclosure of the study information 2006/03/22
Last modified on 2012/03/19

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Basic information
Public title Effect of simvastatin for chronic glomerulonephritis
Acronym Effect of simvastatin for chronic glomerulonephritis
Scientific Title Effect of simvastatin for chronic glomerulonephritis
Scientific Title:Acronym Effect of simvastatin for chronic glomerulonephritis
Region
Japan

Condition
Condition chronic glomerulonephritis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess both renoprotecting and immunomodulatory effects of simvastatin on chronic glomerulonephritis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Amount of proteinuria after administration of simvastatin for 12 weeks
Key secondary outcomes Renal function and immunological findings after administration of simvastatin for 12 weeks

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 simvastatin 10mg/day for 12 weeks
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 1. Patients with IgA nephritis, membranous nephropathy, focal glomerular sclerosis or lupus nephritis
2. Patients with hyperlipidemia
Key exclusion criteria 1. Patients with other lipid-lowering agents
2. Patients with serum creatinine level higher than 1.6mg/dl
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroko Kanda
Organization University of Tokyo
Division name Depertment of Allergy and Rheumatology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Kanda
Organization University of Tokyo
Division name Depertment of Allergy and Rheumatology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email hkanda-tky@umin.ac.jp

Sponsor
Institute Depertment of Allergy and Rheumatology, University of Tokyo
Institute
Department

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
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
2006 Year 03 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
2002 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2002 Year 05 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 18 Day
Last modified on
2012 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000461

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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