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
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
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
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
