UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002483 |
|---|---|
| Receipt number | 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 11:07:14 |
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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
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
a2kamijo@marianna-u.ac.jp
Sponsor or person
Institute
Nephrology and Hypertension, Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003040
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| Registered date | File name |
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