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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002483
Receipt No. R000003040
Scientific Title Clinical Significance of Urinary Liver-Type Fatty Acid Binding Protein in Type 2 Diabetic Nephropathy
Date of disclosure of the study information 2009/09/12
Last modified on 2018/03/22

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Basic information
Public title Clinical Significance of Urinary Liver-Type Fatty Acid Binding Protein in Type 2 Diabetic Nephropathy
Acronym Urinary L-FABP and Diabetic Nephropathy
Scientific Title Clinical Significance of Urinary Liver-Type Fatty Acid Binding Protein in Type 2 Diabetic Nephropathy
Scientific Title:Acronym Urinary L-FABP and Diabetic Nephropathy
Region
Japan

Condition
Condition Type 2 Diabetic Nephropathy
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical usefulness of urinary Liver-type fatty acid binding protein (L-FABP) as a biomarker in impaired type 2 diabetic nephropathy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression to higher stage of diabetic nephropathy.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 type 2 diabetes in the outpatient clinics at the Department of Internal Medicine, St Marianna University School of Medicine Hospital
Key exclusion criteria no history of liver disease, primary kidney disease, cancer, or collagen disease; the degree of hematuria not more severe than the degree of proteinuria; and no hemodialysis
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuko Ikemori
Organization St. Marianna University School of Medicine
Division name Nephrology and Hypertension, Internal Medicine
Zip code
Address 2-16-1 Sugao Miyamaeku Kawasakishi
TEL 81-44-977-8111
Email a2kamijo@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kamijo-Ikemori Atsuko
Organization KZ-001
Division name Nephrology and Hypertension, Internal Medicine
Zip code
Address 2-16-1 Sugao Miyamaeku Kawasakishi
TEL 81-44-977-8111
Homepage URL
Email a2kamijo@marianna-u.ac.jp

Sponsor
Institute Nephrology and Hypertension, Internal Medicine
Institute
Department

Funding Source
Organization Nephrology and Hypertension, Internal Medicine
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
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 09 Month 12 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 Main results already published
Date of protocol fixation
2004 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 03 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information To observe the presence of progression of dibateic nephropathy

Management information
Registered date
2009 Year 09 Month 11 Day
Last modified on
2018 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003040

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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