UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020462