UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019056 |
|---|---|
| Receipt number | 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 00:50:11 |
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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
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
okanokao@matsuyama.jrc.or.jp
Sponsor or person
Institute
Matsuyama redcross hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
