UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Renal resistive index in patients with chronic kidney disease, its effect on renal outcome and cardiovascular events
Title of the study (Brief title)	Renal resistive index in patients with chronic kidney disease, its effect on renal outcome and cardiovascular events
Region	Japan

Condition
Condition	Chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study investigated the relationship among RI, renal function, and proteinuria in CKD patients with or without diabetic nephropathy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Renal outcome (change of proteinuria and decline of renal function)
Key secondary outcomes	Cardiovascular outcome (myocardial infarction, angina pectoris, stroke, aneurysm, peripheral arterial Disease)

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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Inpatients and outpatients
Key exclusion criteria	None
Target sample size	200

Research contact person
Name of lead principal investigator	Hitoshi Sugiyama
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Chronic Kidney Disease and Peritoneal Dialysis
Address	2-5-1 Shikata-Cho, Kita-Ward, Okayama, Okayama 700-8558, Japan
TEL	086-235-7235
Email	hitoshis@md.okayama-u.ac.jp

Public contact
Name of contact person	Hitoshi Sugiyama
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Center for Chronic Kidney Disease and Peritoneal Dialysis
Address	2-5-1 Shikata-cho Kita-ku Okayama 700-8558 Japan
TEL	086-235-7235
Homepage URL
Email	hitoshis@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Others
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	2011 Year 12 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 02 Month 22 Day
Anticipated trial start date	2011 Year 04 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	Published
URL releasing results
Results
Other related information	The total study population included 107 patients (mean age: 50.2 years) with non-diabetic and diabetic CKD, who underwent renal Doppler ultrasonography between April 2009 and March 2011. We investigated the correlation between RI of the renal interlober arteries and multiple clinical parameters, including renal function and proteinuria.

Management information
Registered date	2011 Year 12 Month 20 Day
Last modified on	2018 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008178