UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the risk factors for the progression of diabetic kidney disease
Title of the study (Brief title)	DKD study
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure molecules, which are expected to be involved in renal function failure using blood and urine and to examine correlations with various clinical data.
Basic objectives2	Others
Basic objectives -Others	Measuring of urinary podocalyxin.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	At the time of patient registration, registration (0 M), 12 M, 24 M, 36 M, the following indices are measured. Vitamin D, PTH, AcSDKP, Type IV C, Bteta-2MG, Kim 1, Ngal, 8OHDG, eGFR, UACR, U-podocalyxin. Also, we will also measure urinary podocalyxin (PCX) at the time of visit only for patients who obtained permission.
Key secondary outcomes

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes mellitus
Key exclusion criteria	Under 20 y/o
Target sample size	600

Research contact person
Name of lead principal investigator	Masao Toyoda
Organization	Department of Internal Medicine, Tokai University School of Medicine
Division name	Division of Nephrology, Endocrinology and Metabolism
Address	143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL	0463-93-1121
Email	m-toyoda@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Iwamatsu kanori
Organization	Department of Internal Medicine, Tokai University School of Medicine
Division name	Division of Nephrology, Endocrinology and Metabolism
Address	143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL	0463-93-1121
Homepage URL
Email	k-iwamstu@tsc.u-tokai.ac.jp

Sponsor
Institute	Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 11 Month 07 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 10 Month 23 Day
Anticipated trial start date	2015 Year 01 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	NONE

Management information
Registered date	2017 Year 11 Month 07 Day
Last modified on	2017 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034099