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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019056
Receipt No. R000022027
Scientific Title Research for the relation between urinary L-FABP and CKD progression
Date of disclosure of the study information 2015/10/02
Last modified on 2016/09/20

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Basic information
Public title Research for the relation between urinary L-FABP and CKD progression
Acronym Urinary L-FABP and CKD progression
Scientific Title Research for the relation between urinary L-FABP and CKD progression
Scientific Title:Acronym Urinary L-FABP and CKD progression
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To predict the progression of CKD by urinary L-FABP
Basic objectives2 Others
Basic objectives -Others Relation between the etiology of CKD and urinary L-FABP
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between the change of eGFR in the past one year and urinary L-FABP
Key secondary outcomes

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 Prevention
Type of intervention
Other
Interventions/Control_1 Single measurement of urinary L-FABP
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
18 years-old <
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Non-dialysis CKD patients followed for more than one year in our hospital
Key exclusion criteria CKD patients who developed to AKI during past one year
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Oka
Organization Matsuyama redcross hospital
Division name Kidney center
Zip code
Address 1 Bunkyocho, Matsuyama
TEL 089-924-1111
Email okanokao@matsuyama.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Oka
Organization Matsuyama redcross hospital
Division name Kidney center
Zip code
Address 1 Bunkyocho, Matsuyama
TEL 089-924-1111
Homepage URL
Email okanokao@matsuyama.jrc.or.jp

Sponsor
Institute Matsuyama redcross hospital
Institute
Department

Funding Source
Organization Matsuyama redcross hospital
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
2015 Year 10 Month 02 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
This study demonstrated a moderate correlation between the slope of eGFR and L-FABP. However, the correlation between urine protein and slope of eGFR was stronger than that of L-FABP and additional prognostic value of L-FABP to urine protein could not be showen.
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
2015 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 07 Day
Last follow-up date
2015 Year 10 Month 31 Day
Date of closure to data entry
2015 Year 11 Month 14 Day
Date trial data considered complete
2015 Year 11 Month 14 Day
Date analysis concluded
2015 Year 11 Month 14 Day

Other
Other related information

Management information
Registered date
2015 Year 09 Month 17 Day
Last modified on
2016 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022027

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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