UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009160 |
|---|---|
| Receipt number | 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 14:15:53 |
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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
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
yujisaka@kcn.ne.jp
Sponsor or person
Institute
Osaka City University Department of Cardiovascular Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010723
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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