UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006921
Receipt number R000008178
Scientific Title Renal resistive index in patients with chronic kidney disease, its effect on renal outcome and cardiovascular events
Date of disclosure of the study information 2011/12/20
Last modified on 2018/06/19 15:48:19

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Basic information

Public title

Renal resistive index in patients with chronic kidney disease, its effect on renal outcome and cardiovascular events

Acronym

Renal resistive index in patients with chronic kidney disease, its effect on renal outcome and cardiovascular events

Scientific Title

Renal resistive index in patients with chronic kidney disease, its effect on renal outcome and cardiovascular events

Scientific Title:Acronym

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

1st name
Middle name
Last name Hitoshi Sugiyama

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Chronic Kidney Disease and Peritoneal Dialysis

Zip code


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

1st name
Middle name
Last name Hitoshi Sugiyama

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Center for Chronic Kidney Disease and Peritoneal Dialysis

Zip code


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 or person

Institute

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Institute

Department

Personal name



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)



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

2011 Year 12 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


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

2011 Year 02 Month 22 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008178


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name