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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017677
Receipt No. 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 2017/12/24

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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
Email 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
Email in3089@poh.osaka-med.ac.jp

Sponsor
Institute Department of Cardiology
Osaka Medical College
Institute
Department

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
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 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
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
2017 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020462

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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