UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001508 |
|---|---|
| Receipt number | R000001717 |
| Scientific Title | Osaka study of Nicorandil effect on Chronic Kidney Disease |
| Date of disclosure of the study information | 2009/01/10 |
| Last modified on | 2019/11/26 08:57:58 |
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Basic information
Public title
Osaka study of Nicorandil effect on Chronic Kidney Disease
Acronym
ON-CKD study
Scientific Title
Osaka study of Nicorandil effect on Chronic Kidney Disease
Scientific Title:Acronym
ON-CKD study
Region
| Japan |
Condition
Condition
Chronic kidney disease
Ischemic coronary disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate weather endothelial function of chronic kidney disease patients with risk factors for cardiovascular diseases could be improved by nicorandil.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Endothelial function measured by reactive hyperemia by pulse amplitude tonometry (RH-PAT) and augmentation index and cardiac stress marker.
Key secondary outcomes
The primary end point is death from all causes, morbidity and mortality from cardiovascular causes, a composite of myocardial infarction, stroke, first hospitalization for heart failure or unstable angina, coronary or peripheral
revascularization, or death from cardiovascular causes.
The time to the first event of
the composite end point of a doubling of the serum creatinine concentration, end-stage renal disease, or death is also set as a primary end point.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nicorandil, 15mg/day, per os
Interventions/Control_2
No use of nicorandil
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
(1)Age, above 20 and below 75
(2)Chronic kidney disease.
(3)Patients with angina or silent myocardial ischemia
(4) Patients with endothelial dysfunction
(5) Patients who are obtained informed consent
Key exclusion criteria
(1)Liver cirrhosis
(2)Previous organ transplantation
(3)Administered anti-cancer drugs within 2 years
(4)Non Japanese
(5)Known HIV/AIDS
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Isaka |
Organization
Osaka University School of Medicine
Division name
Department of Nephrology
Zip code
567-0085
Address
Box A8, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3632
y-isaka@kid.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Isaka |
Organization
Osaka University Hospital
Division name
Department of Nephrology
Zip code
567-0085
Address
Box A8, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3632
Homepage URL
y-isaka@kid.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University School of Medicine
Department of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Osaka University School of Medicine
Department of Nephrology
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
Osaka University
Address
2-15 Yamadaoka, Suita, Osaka
Tel
06-6979-5685
umezome@hp-crc.med.osaka-u.ac.jp
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
| 2009 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000001717
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000001717
Number of participants that the trial has enrolled
19
Results
Association with BNP reduction was observed.
Results date posted
| 2019 | Year | 11 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Men and women aged at 20 to 75 who were being treated for advanced stages of CKD
Participant flow
Patients were recruited at the outpatient ward.
Adverse events
None observed.
Outcome measures
The BNP concentration.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2008 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 15 | Day |
Last modified on
| 2019 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001717
| 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 |
