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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014225
Receipt No. 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

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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
Institute JRAS Resitry
Institute
Department

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
URL(English) https://upload.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


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