UMIN-CTR Clinical Trial

Basic information
Public title	Influence of XOI, Febuxostat, on Vascular Function in Patients with Hyperuricemia and Cardiovascular Risk Factors
Acronym	Jichi Medical Univertisy XOI study (J-XOI study)
Scientific Title	Influence of XOI, Febuxostat, on Vascular Function in Patients with Hyperuricemia and Cardiovascular Risk Factors
Scientific Title:Acronym	Jichi Medical Univertisy XOI study (J-XOI study)
Region	Japan

Condition
Condition	(1) Treated or untreated hyperuricemia and (2) Hypertension, ischemic heart disease, diabetes, dyslipidemai, chronic kidney disease (CKD), history of cerebrovascular diease, aortic dissection, or metabolic syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test the hypothesis that xanthine oxidase inhibitor Febuxostat is effective in improving vascular functions including endothelial function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of flow-mediated dilatation (FMD), pulse wave velocity (PWV), central pressure, carotid intima-media thickness (IMT) at 6 months after the intervention.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Febuxostat Febuxostat will be administered from 10mg, and then increaed to 20 and 40mg, after 4wks and 8wks, respectively. Serum uric acid is measured before increasing febuxostat, and if uric acid <6.0mg/dl, febuxostat will not be increased.
Interventions/Control_2	Allopurinol Allopurinol will be started from 100mg/day and will be incraed to 200mg after 4 wks. Follow up period is 6 months
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) Treated or untreated patients with Hyperuricemia (2) Hypertension, ischemic heart disease, diabetes, dyslipidemai, chronic kidney disease (CKD), history of cerebrovascular diease, aortic dissection, or metabolic syndrome (3) Age 20 years or more (4) Patients who are treated with uric acid lowering agens (5) Patinets from which informed consent is obtained and who are able to be followed for 6 months
Key exclusion criteria	(1) Age < 20years (2)Patients having gout attack at the time of eligibility judgment (3)Patients with renal failure, or dialysis (4)Patients with hepatic impairment (5)Patinets having malignancy, chemotherapy, psoriasis vulgaris, polycythemia, hemolytic anemia, myopathy, PRPP synthetaze activation, Lesch-Nyhan syndrome (HPRT deficiency), Diabetes insipidus, or other severe diseases (6)Patients with hypersensitivity to febuxostat (7)Treated patients with mercaptopurine or azathioprine, aciclovir, and didanosine (8)Pregnant female, lactation femal, hoping gestation (9)Patients whom study physicians consider as not eligible.
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Kazuomi Middle name Last name Kario
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Medicine
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL	0285-58-7344
Email	kkario@jichi.ac.jp

Public contact
1st name of contact person	1st name Kazuomi Middle name Last name Kario
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Medicine
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL	0285-58-7344
Homepage URL
Email	kkario@jichi.ac.jp

Sponsor
Institute	Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	Teijin Pharma
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Support Center for Clinical Investigation Jichi Medical University
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
Tel	0285-58-8933
Email	rinri@jichi.ac.jp

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	国際医療福祉大学病院（栃木県）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 28 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	39
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	Completed
Date of protocol fixation	2015 Year 08 Month 14 Day
Date of IRB	2015 Year 08 Month 14 Day
Anticipated trial start date	2015 Year 10 Month 29 Day
Last follow-up date	2018 Year 05 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	2015 Year 10 Month 28 Day
Last modified on	2019 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022584