UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015137 |
|---|---|
| Receipt number | R000008137 |
| Scientific Title | Japan multi-central Renal Artery Stent study |
| Date of disclosure of the study information | 2014/09/12 |
| Last modified on | 2016/09/13 15:50:46 |
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Basic information
Public title
Japan multi-central Renal Artery Stent study
Acronym
J-RAS Study
Scientific Title
Japan multi-central Renal Artery Stent study
Scientific Title:Acronym
J-RAS Study
Region
| Japan |
Condition
Condition
Atheroscrerotic renal artery Stenosis
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of renal artery stent placement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
eGFR, blood pressure, BNP, urinalysis, urinary albumin
Key secondary outcomes
success rate, MAE, blood pressure, renal size, drugs, central blood pressure, uric toxin
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) ARAS patients
2) region size <18mm and diameter between 4-6mm
inculuding
1) clinical symptom
2) visual stenosis >70%
3) PSV> 180cm/sec and blood pressure differece>20mmHg
Key exclusion criteria
1) eGFR<10 ml/min
2) renal atrophy size<7cm
3) renal artery obstruction
4) calcificaiton
5) bifercation
6) vessels with clots
7) bleeding
8) perforation
9) anyurism
10) inappropriate case
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ITO Sadayoshi |
Organization
Tohoku University Hospital
Division name
Department of Clinical Biology and Hormonal Regulation
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai980-8574, Japan
TEL
022-717-7163
takaabe@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ABE Takaaki |
Organization
Tohoku University Hospital
Division name
Department of Clinical Biology and Hormonal Regulation
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai980-8574, Japan
TEL
022-717-7163
Homepage URL
takaabe@med.tohoku.ac.jp
Sponsor or person
Institute
J-RAS Resitry
Institute
Department
Personal name
Funding Source
Organization
original
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
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
東北大学大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 12 | 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
Renal stenting is effective in Japanese patients with renal artery stenosis for reducing blood pressure and preserving renal function. ujihara M, Yokoi Y., Abe T., Soga Y., Yamashita T., Miyashita Y., Nakamura M., Yokoi H. and Ito S; J-RAS Study Investigators. Clinical Outcome of Renal Artery Stenting for Hypertension and Chronic Kidney Disease up to 12 Months in the J-RAS Study.
Circ J. 79: 351-9, 2015
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
| 2010 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
background, renal function, blood pressure, Echo, renal anigogram, examination data, blood, urine, drugs, MAE
Management information
Registered date
| 2014 | Year | 09 | Month | 12 | Day |
Last modified on
| 2016 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008137
