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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009160
Receipt No. R000010723
Scientific Title Influence on estimated glomerular filtration rate in patients with ischemic heart disease and hyperuricemia medicated by febuxostat.
Date of disclosure of the study information 2012/10/22
Last modified on 2013/12/17

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Basic information
Public title Influence on estimated glomerular filtration rate in patients with ischemic heart disease and hyperuricemia medicated by febuxostat.
Acronym Influence on estimated glomerular filtration rate in patients with ischemic heart disease and hyperuricemia medicated by febuxostat.
Scientific Title Influence on estimated glomerular filtration rate in patients with ischemic heart disease and hyperuricemia medicated by febuxostat.
Scientific Title:Acronym Influence on estimated glomerular filtration rate in patients with ischemic heart disease and hyperuricemia medicated by febuxostat.
Region
Japan

Condition
Condition Ischemic heart disease patients with hyperuricemia
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the influence of febuxostat on estimated glomerular filtration rate(eGFR) in patients with ischemic heart disease and hyperuricemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of estimated glomerular filtration rate(eGFR) between two groups(
control group and medicated group).
Key secondary outcomes 1)Changes of eGFR between each two groups(control group and medicated group).
2)Changes of uric acid levels,
ratio of achiving less than 6.0mg/dl of uric acid levels,
changes of microalbuminuria/creatinine,
changes of creatinene clearance,
changes of C cystatin levels
3)Death, cardiovascular events(acute myocardial infarction, target vessel revascularization, new onset angina pectoris, congestive heart failure, cerebral infarction)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Control group(nutrition education)
Interventions/Control_2 Febuxostat group(febuxostat+nutrition education)
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)7.0mg/dl<uric acid levels<9.0mg/dl
2)Patients with ischemic heart disease
3)30ml/min<eGFR<90ml/min
Key exclusion criteria 1)Patients with severe renal injury
(eGFR<30ml/min)
2)Patients with severe liver injury
3)Patients with severe heart failure
(NYHA Class4)
4)Patients with acute myocardial infarction within three months
5)Ineligible patients for any other reasons
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Yoshiyama
Organization Osaka City University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka
TEL 06-6645-3801
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Sakanoue
Organization Higashisumiyoshi Morimoto Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 3-2-66, Takaai, Higashisumiyoshi-ku, Osaka
TEL 06-6606-0010
Homepage URL
Email yujisaka@kcn.ne.jp

Sponsor
Institute Osaka City University Department of Cardiovascular Medicine
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 東住吉森本病院 循環器内科
Higashisumiyoshi Morimoto Hospital Department of Cardiovascular Medicine

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 22 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 Enrolling by invitation
Date of protocol fixation
2012 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 22 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 22 Day
Last modified on
2013 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010723

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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