UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007308 |
|---|---|
| Receipt number | R000008616 |
| Scientific Title | RenalGuard System to Prevent Contrast-Induced Acute Kidney Injury in Japan |
| Date of disclosure of the study information | 2012/02/16 |
| Last modified on | 2018/09/13 17:53:03 |
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Basic information
Public title
RenalGuard System to Prevent Contrast-Induced Acute Kidney Injury in Japan
Acronym
RESPECT KIDNEY
Scientific Title
RenalGuard System to Prevent Contrast-Induced Acute Kidney Injury in Japan
Scientific Title:Acronym
RESPECT KIDNEY
Region
| Japan |
Condition
Condition
Chronic kidney disease with coronary aretry disease or peripheral artery disease
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of RenalGuard System in the prevention of contrast-induced nephropathy in the setting of a catheterization laboratory
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Combined incidence of contrast-induced nephropathy (CIN) and serious in-hospital therapy-related adverse events
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
RenalGuard group
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
Male or non-pregnant female equal or greater than the age 20 years old and is able to provide informed consent.
Subject is scheduled to undergo an catheterization procedure that is expected to use at least 75 ml of intraarterial contrast.
Subject has moderate to severe kidney impairement-eGFR<45 ml/min/1.73m2 and more than 30 % of ejection fraction of left ventricle.
Key exclusion criteria
Class 3 or 4 chronic heart failure.
Subject is anuric or has undergone renal replacement therapy, or has a known inability to have a Foley catheter placed.
Subject has received contrast within 7 days of procedure.
Subject has a known hypersensitivity to furosemide and/or the contrast agent being used.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Michishita |
Organization
Federation of National Public Service Personnel Mutual Aid Associations, Yokohama Sakae Kyosai Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
132 Katura-cho, Sakae-ku, Yokohama-shi
TEL
045-891-2171
i-michishita@yokohamasakae.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Nozue |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Divison of Cardiology, Department of Internal Medicine
Zip code
Address
132 Katsura-cho, Sakae-ku, Yokohama-shi
TEL
045-891-2171
Homepage URL
nozue2493@yahoo.co.jp
Sponsor or person
Institute
Yokohama Sakae Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama Sakae Kyosai Hospital
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 16 | 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
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 16 | Day |
Last modified on
| 2018 | 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=R000008616
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
