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

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 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


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

Value
https://center6.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