UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Vascular lesions in diabetic nephropathy and cardiovascular events
Title of the study (Brief title)	Diabetic nephropathy and cardiovascular events
Region	Japan

Condition
Condition	Diabetic nephropathy
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to investigate the relation between histological findings and future events in biopsy-proven diabetic nephropathy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cardiovascular events
Key secondary outcomes	end stage renal disease and all-cause mortality

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	18 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Biopsy-proven diabetic nephropathy
Key exclusion criteria	lost to follow-up
Target sample size	500

Research contact person
Name of lead principal investigator	Masaru Matsui
Organization	Nara Medical University
Division name	Department of Nephrology
Address	840, Shijo-cho, Kashihara City
TEL	0744-22-3051
Email	matui-o-v2008420@olive.plala.or.jp

Public contact
Name of contact person	Masaru Matsui
Organization	Nara Medical University
Division name	Department of Nephrology
Address	840, Shijo-cho, Kashihara City
TEL	0744-22-3051
Homepage URL
Email	matui-o-v2008420@olive.plala.or.jp

Sponsor
Institute	Nara Medical 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)

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	2018 Year 02 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 03 Month 01 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	Renal arteriolar hyalinosis, not intimal thickening in larger arteries, is associated with cardiovascular events in patients with biopsy-proven diabetic nephropathy

Management information
Registered date	2018 Year 02 Month 02 Day
Last modified on	2018 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035543