UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000892 |
|---|---|
| Receipt number | R000001073 |
| Scientific Title | An Open-label Controlled Trial to Compare the Prevalence of Radiocontrast Induced Nephropathy between Iohexol and Iomeprol after Coronary Angiography in Patients with Chronic Kidney Disease |
| Date of disclosure of the study information | 2007/12/01 |
| Last modified on | 2007/11/14 20:44:17 |
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Basic information
Public title
An Open-label Controlled Trial to Compare the Prevalence of Radiocontrast Induced Nephropathy between Iohexol and Iomeprol after Coronary Angiography in Patients with Chronic Kidney Disease
Acronym
Comparison of the Prevalence of Radiocontrast Induced Nephropathy between Iohexol and Iomeprol after Coronary Angiography in Chronic Kidney Disease Patients
Scientific Title
An Open-label Controlled Trial to Compare the Prevalence of Radiocontrast Induced Nephropathy between Iohexol and Iomeprol after Coronary Angiography in Patients with Chronic Kidney Disease
Scientific Title:Acronym
Comparison of the Prevalence of Radiocontrast Induced Nephropathy between Iohexol and Iomeprol after Coronary Angiography in Chronic Kidney Disease Patients
Region
| Japan |
Condition
Condition
Radiocontrast induced nephropathy in chronic kidney disease patients
Classification by specialty
| Cardiology | Nephrology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the prevalence of radiocontrast induced nephropahty between two low osmotic contrast medium, Iohexol and Iomeprol, after coronary angiography in patients with chronic kidney disease
Basic objectives2
Others
Basic objectives -Others
Another aim of this study it to identify the risk factor of radiocontrast induced nephropathy in chronic kidney disease patients
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in serum creatinine, estimated GFR and serum Cystatin C during two weeks after coronary angiography
Key secondary outcomes
Kidney function after one year
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Injection of Iohexol for contrast medium during coronary angiography(control group)
Interventions/Control_2
Injection of Iomeprol for contrast medium during coronary angiography
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The eGFR is 60ml/min/1.73m2 or less
Key exclusion criteria
Contraindication of radiocontrast agent
Congestive heart failure(NYHA III,IV)
Acute coronary syndrome
Malignancy
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Terumasa Hayashi |
Organization
Izumisano Municipal Hospital
Rinku General Medical Center
Division name
Department of Nephrology
Zip code
Address
2-23 Rinku-Orai Kita Izumisano Osaka 598-8577 Japan
TEL
072-469-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Terumasa Hayashi |
Organization
Izumisano Municipal Hospital Rinku General Medical Center
Division name
Department of Nephrology
Zip code
Address
2-23 Rinku-Orai Kita Izumisano Osaka 598-8577 Japan
TEL
072-469-3111
Homepage URL
t-hayashi@rgmc.izumisano.osaka.jp
Sponsor or person
Institute
Department of Nephrology
Izumisano Municipal Hospital
Rinku General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2007 | Year | 12 | Month | 01 | 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
Date of protocol fixation
| 2007 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 14 | Day |
Last modified on
| 2007 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001073
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
