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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008544
Receipt No. R000008057
Scientific Title Nicorandil-CKD study
Date of disclosure of the study information 2012/07/26
Last modified on 2012/07/26

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Basic information
Public title Nicorandil-CKD study
Acronym Nicorandil-CKD study
Scientific Title Nicorandil-CKD study
Scientific Title:Acronym Nicorandil-CKD study
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the protective effect of Nicorandil against CIN in patients with poor renal function undergoing PCI, we conducted a prospective randomized trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Incidences of CIN during 1 month
Key secondary outcomes Percent rise in serum creatinine
Percent rise in estimated GFR

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Patient were divided into 2 groups, the saline group and Nicorandil group.
In both group, saline was infused 1ml/kg/h 4 hours prior to PCI and after 20hours.
Interventions/Control_2 To Nicolandil group, Nicolandil was infused at 0.096mg/kg/hr 4hours prior to PCI and after 20hours.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who subsequently undergo PCI and who had higher cystatin C level than normal cyctatin C level(male 0.95mg/L, female 0.8mg/L).
Key exclusion criteria heart failure
acute coronary syndrome
pediatrics
hemodialysis
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Minatoguchi
Organization Department of Cardiology, Respirology, and Nephrology, Gifu University Graduate School of Medicine
Division name The second departure of internal medicine
Zip code
Address 1-1 Yanagito Gifu city
TEL 058-328-6000
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Nishigaki
Organization Gifu university hospital
Division name The second departure of internal medicine
Zip code
Address 1-1 Yanagito Gifu city
TEL 058-328-6000
Homepage URL
Email nissy@gifu-u.ac.jp

Sponsor
Institute Department of Cardiology, Respirology, and Nephrology, Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 岐阜大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 26 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 Open public recruiting
Date of protocol fixation
2007 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
2012 Year 04 Month 01 Day
Date trial data considered complete
2012 Year 05 Month 01 Day
Date analysis concluded
2012 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 26 Day
Last modified on
2012 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008057

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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