UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007168 |
|---|---|
| Receipt number | R000008447 |
| Scientific Title | Development of new diagnostic method of chronic kidney disease using novel biomarkers in blood and urine |
| Date of disclosure of the study information | 2012/01/30 |
| Last modified on | 2020/03/09 10:23:35 |
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Basic information
Public title
Development of new diagnostic method of chronic kidney disease using novel biomarkers in blood and urine
Acronym
Development of new diagnostic method of chronic kidney disease using novel biomarkers in the blood and the urine
Scientific Title
Development of new diagnostic method of chronic kidney disease using novel biomarkers in blood and urine
Scientific Title:Acronym
Development of new diagnostic method of chronic kidney disease using novel biomarkers in the blood and the urine
Region
| Japan |
Condition
Condition
chronic kidney disease including diabetic nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Discovering the most valuable biomarkers and their combination so as to diagnose chronic kidney disease (CKD) including diabetic nephropathy and to estimate prognosis of patients with CKD
Basic objectives2
Others
Basic objectives -Others
Enhancement of the clinical skills through enabling early diagnosis of CKD, classifying CKD stage and estimating prognosis of patients with CKD
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gradient of estimated glomerular filtration rate
Key secondary outcomes
All-cause mortality, introducing renal replacement therapy or the doubling of serum creatinine value, cardiovascular event
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
| 16 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inpatients and outpatients at the age of 16 and upper with CKD including diabetic nephropathy
Key exclusion criteria
Patients with mental disorder, and patients receiving dialysis therapy or renal transplantation
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Hirofumi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Medicine and Clinical Science
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama 700-8558 Japan
TEL
086-235-7235
sannai@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hiroshi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Medicine and Clinical Science
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama 700-8558 Japan
TEL
086-235-7235
Homepage URL
morinaga@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
None
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama City
Tel
086-235-6762
MAE6605@adm.okayama-u.ac.jp
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
| 2012 | Year | 01 | Month | 30 | 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
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
| 2011 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
This study is designed as an objective, prospective, single-center study to be done over 5-year observational period. Inpatients and outpatients of Okayama University Hospital with chronic kidney disease can be enrolled. Following biomarkers in blood and urine samples will be measured at Okayama University and Otsuka Pharmaceutical Co., Ltd. Tokushima Factory.
CKD panel: ADMA, SDMA, AOPP, 8-OHdG, oxLDL, IL-6, Trefoil factor 1-3 and protein related to oxidative stress.
Diabetic nephropathy panel: type IV collagen, TGF-beta1, CTGF, VEGF, MCP-1 and agents associated with glycation, inflammation and oxidation.
Management information
Registered date
| 2012 | Year | 01 | Month | 30 | Day |
Last modified on
| 2020 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008447
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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