UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008447