UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014225
Receipt number R000016570
Scientific Title Muti-center registry study for stent therapy for renal artery stepsons
Date of disclosure of the study information 2014/07/04
Last modified on 2014/06/10 21:16:05

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Basic information

Public title

Muti-center registry study for stent therapy for renal artery stepsons

Acronym

J-RAS Registry

Scientific Title

Muti-center registry study for stent therapy for renal artery stepsons

Scientific Title:Acronym

J-RAS Registry

Region

Japan


Condition

Condition

Atheroscirerotic renal artery stenosis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The therapeutic effect of renal artery stenting to artero-screrotic renal artery stenosis in uncertain.
So. the aim of this study is to perform the prospective study of the patients who get renal artery stenting in Japan. In addition, metaboloic analysis will also performed to generate new biomarker of renal ischemia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Renal function (eGFR), blood pressure, BNP, Urinalysis, microalbumiuira,

Key secondary outcomes

Performance, Complication, Major adverse effect , Administration by CHF, Renal hemodynamics, Renal size, Change of anti-hypertensive drugs, biomarkers, Central blood pressure (optional), Blood test and uremic toxins


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Renal artery stenting

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

Arteiosclerotic renal aretey stenosis patinet
20 yo>
1, clinical significance
2, Poor renal hemodynamics
3, PSV>180cm/sec and RAR>3.5

Key exclusion criteria

1, eGFR <10 ml/min
2, renal size <7cm
3, obstructive renal artery
4, severe renal artery calcification
5, branch lesion
6, hematoma or thrombosis
7, hemorrhagic diathesis
8, leakage
9, aneurysm

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sadayoshi Ito

Organization

Tohoku University

Division name

Clinical Biology and hormonal regulation

Zip code


Address

1-1 Seiryo-cho, Aoba-ku, Sendai Japan

TEL

022-717-7163

Email

db544@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takaaki ABE

Organization

Tohoku University

Division name

Clinical Biology and hormonal regulation

Zip code


Address

1-1 Seiryo-cho, Aoba-ku, Sendai Japan

TEL

022-717-7163

Homepage URL


Email

takaabe@med.tohoku.ac.jp


Sponsor or person

Institute

JRAS Resitry

Institute

Department

Personal name



Funding Source

Organization

Johnson and Johnson

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

2014 Year 07 Month 04 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

No longer recruiting

Date of protocol fixation

2010 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 01 Month 01 Day

Last follow-up date

2014 Year 04 Month 30 Day

Date of closure to data entry

2014 Year 04 Month 30 Day

Date trial data considered complete

2014 Year 05 Month 01 Day

Date analysis concluded

2014 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 06 Month 10 Day

Last modified on

2014 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016570


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name