UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017677 |
|---|---|
| Receipt number | R000020462 |
| Scientific Title | Effect of vascular remodeling under uric acid control by xanthine oxidase inhibitor , febuxostat |
| Date of disclosure of the study information | 2016/11/14 |
| Last modified on | 2020/11/13 10:55:16 |
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Basic information
Public title
Effect of vascular remodeling under uric acid control by xanthine oxidase inhibitor , febuxostat
Acronym
Effect of vascular remodeling under uric acid control
Scientific Title
Effect of vascular remodeling under uric acid control by xanthine oxidase inhibitor , febuxostat
Scientific Title:Acronym
Effect of vascular remodeling under uric acid control
Region
| Japan |
Condition
Condition
Hyperuricemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of FGF23/Klotho etc as an cardiovascular remodeling indicator by uric acid lowering therapy with febuxostat in patients with hyperuricemia using carotid intima-media thickness (IMT)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage change in FGF23/Klotho associated factors after 24 months from baseline as measured by carotid ultrasound imaging
Key secondary outcomes
1) FGF23/Klotho associated factors (FGF21,FGF19 etc), Parathyroid hormone levels at baseline, after 6 months, 12 months, and 24 months, and the amount of change and %change from baseline
2) Values of the following cardiovascular function parameters at baseline, after 12 months, and 24 months, and the amount of change and %change from baseline (arbitrary items)
Echocardiography, carotid ultrasound imaging, cardiovascular examination, blood pressure, heart rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Febuxostat group
(patients receiving febuxostat)
Interventions/Control_2
Control group
(patients not receiving febuxostat)
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) Patients aged >=20 years at the time informed consent is obtained (both sexes)
2) Patients with asymptomatic hyperuricemia with serum uric acid >7.0 mg/dL
3) Patients with the maximum IMT >=1.1 mm
4) Patients who gave written informed consent to participate in the study
Key exclusion criteria
1) Patients being treated with any of the following antihyperuricemic agents within 8 weeks before confirmation of the eligibility criteria:
Allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, febuxostat
2) Patients being treated with any of the following agents at the time of confirmation of the eligibility criteria:
Mercaptopurine hydrate, azathioprine, vidarabine, didanosine
3) Patients who have undergone an operation or who have severe infections or serious injury at the time of confirmation of the eligibility criteria
4) Patients who had myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty/bypass surgery, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient cerebral ischemic attack within 3 months before confirmation of the eligibility criteria
5) Patients with cardiac dysfunction (NYHA class IV)
6) Patients with gouty tophus, or those who have subjective symptoms of gout arthritis within 1 year before confirmation of the eligibility criteria
7) Patients with severe renal dysfunction (eGFR <30 mL/min or patients under dialysis)
8) Patients with severe liver dysfunction (AST or ALT <=2 times the upper limit of the institutional standard value)
9) Patients with a complication or a disease history (e.g. malignant tumor) who are considered not eligible for the study by the attending doctor
10) Patients with a history of hypersensitivity to febuxostat
11) Pregnant, possibly pregnant, or lactating women or those who wish to become pregnant during participation in the study
12)Patients who underwent CEA or CAS surgery
13) Patients who are considered not eligible for the study by the attending doctor due to other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Hoshiga |
Organization
Osaka Medical College
Division name
Department of Cardiology
Zip code
Address
2-7 Daigakucho, Takatuski, Osaka
TEL
072-683-1221
in1026@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko Kanzaki |
Organization
Osaka Medical College
Division name
Department of Cardiology
Zip code
Address
2-7 Daigakucho, Takatuski, Osaka
TEL
072-683-1221
Homepage URL
in3089@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of Cardiology
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology
Osaka Medical College
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
大阪医科大学 循環器内科
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 26 | Day |
Last modified on
| 2020 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020462
