UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000001508
Receipt No. 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 (Ver. 15)

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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
Email 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
Email y-isaka@kid.med.osaka-u.ac.jp

Sponsor
Institute Osaka University School of Medicine
Department of Nephrology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001717