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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007168
Receipt No. 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 2017/08/04

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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
Middle name
Last name Hirofumi Makino
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Medicine and Clinical Science
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama 700-8558 Japan
TEL 086-235-7235
Email sannai@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Morinaga
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Medicine and Clinical Science
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama 700-8558 Japan
TEL 086-235-7235
Homepage URL
Email morinaga@okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2009 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2017 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008447

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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