UMIN-CTR Clinical Trial

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

(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

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

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

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Teijin Pharma

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国際医療福祉大学病院（栃木県）

Date of disclosure of the study information

2015

Year

10

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

10

Month

28

Day

Last modified on

2019

Year

03

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022584