UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001843 |
|---|---|
| Receipt number | R000002219 |
| Scientific Title | Early detection of acute kidney injury by newly established biomarkers |
| Date of disclosure of the study information | 2009/04/02 |
| Last modified on | 2014/02/27 10:08:38 |
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Basic information
Public title
Early detection of acute kidney injury by newly established biomarkers
Acronym
New biomarkers in acute kidney injury
Scientific Title
Early detection of acute kidney injury by newly established biomarkers
Scientific Title:Acronym
New biomarkers in acute kidney injury
Region
| Japan |
Condition
Condition
Acute kidney injury (AKI)
Classification by specialty
| Nephrology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether levels of urinary L-type fatty acid-binding protein (L-FABP) is a useful biomarker for early detection of AKI or monitoring the disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate whether levels of urinary L-FABP is a useful biomarker for early detection of AKI or monitoring the disease.
Key secondary outcomes
1) Measurement of urinary L-FABP and another biomarkers
2) Comparison urinary L-FABP level with severity of AKI
3) Determination of cut off values of the biomarkers in the detection of AKI
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Urine samples are obtained from patients who are admitted into St.marianna university hospital.Inclusion criteria is following:
1.Patients whose serum-creatinine level are less than 1.5 mg/dl at the start. The kidney transplant patient who is doubted of acute rejection and admitted to urology or the patient of admitted to cardiovascular surgery for elective operation.
2.Patients whose serum creatinine levels were equal to or more than 1.5 mg/dl, and whose conditions were included into modification RIFLE criteria.
3.The patient whose informed consent was obtained.
Key exclusion criteria
1.The patients with chronic renal failure
2.The patients with atrophic kidney
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuomi Matsui |
Organization
St.Marianna University School of Medicine
Division name
Department of nephrology and hypertension
Zip code
Address
2-16-1 Sugao,miyamae-ku,kawasaki,kanagawa,216-8511,Japan
TEL
044-977-8111
m.katsuomi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuomi Matsui |
Organization
St.Marianna University School of Medicine
Division name
Department of nephrology and hypertension
Zip code
Address
2-16-1 Sugao,miyamae-ku,kawasaki,kanagawa,216-8511,Japan
TEL
044-977-8111
Homepage URL
m.katsuomi@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine,Department of nephrology and hypertension
Institute
Department
Personal name
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
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 | 04 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruting
Management information
Registered date
| 2009 | Year | 04 | Month | 02 | Day |
Last modified on
| 2014 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002219
