UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026765
Receipt number R000030728
Scientific Title Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat on serum uric acid, endothelial function and markers for kidney injury
Date of disclosure of the study information 2017/03/30
Last modified on 2023/04/05 10:19:06

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Basic information

Public title

Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat on serum uric acid, endothelial function and markers for kidney injury

Acronym

Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat.

Scientific Title

Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat on serum uric acid, endothelial function and markers for kidney injury

Scientific Title:Acronym

Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat.

Region

Japan


Condition

Condition

Hyperuremia

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of topiroxostat versus febuxostat on uric acid and endothelial function in hyperuremic patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Flow-mediated vasodilation in forearm, serum level of uric acid, marker of early-staged kidney diseases 12 weeks after administration

Key secondary outcomes

Serum level of lipid, glucose, HbA1c and liver function, Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL),
12 weeks after administration


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

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

Topiroxostat 40-160mg /day for 12 weeks
> Febuxostat 10-40mg /day for 12 weeks

Interventions/Control_2

Febuxostat 10-40mg/day for 12 weeks
> Topiroxostat 40-160mg/day for 12 weeks

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Poor-controlled hyperuricemia despite adequate lifestyle improvement for 8 weeks.(UA>8mg/dl)
2) 20 years of age or more
3) female or male
4) outpatients
5) eGFR>30ml/min./1.73m2
6) Subjects who can get the consent to join this study

Key exclusion criteria

1) Subjects who has a history of allergy to topiroxostat or febuxostat.
2) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
3) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits.
4) Subjects who has already taken mercaptopurine hydrate, azathioprine, vidarabine, didanosine.
5) Subjects whose doctor in charge do not agree to join the trial
6) Subjects who has past medical histories of active hemorrhage, ulcer, stroke, optical hemorrhage, hemorrhagic tendency.

Target sample size

33


Research contact person

Name of lead principal investigator

1st name Hirotaka
Middle name
Last name Ezaki

Organization

Tokorozawa Heart Center

Division name

Department of Cardiology

Zip code

359-1142

Address

2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN

TEL

04-2940-8611

Email

hirotakaezaki@gmail.com


Public contact

Name of contact person

1st name Misa
Middle name
Last name Ito

Organization

Self-Defense Forces Fuji Hospital

Division name

Department of Internal Medicine

Zip code

410-1431

Address

481-27 Subashiri, Oyama, Shunto, Shizuoka, Japan 410-1431

TEL

0550-75-2311

Homepage URL


Email

jumpimjumpim@gmail.com


Sponsor or person

Institute

Tokorozawa Heart Center

Institute

Department

Personal name



Funding Source

Organization

Foundation for Promotion of Defense Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

Self-Defense Forces Fuji Hospital
National defense medical college hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

The ethics committee of Tokorozawa Heart Center

Address

2-61-11 Kamiarai, Tokorozawa, Saitama, Japan

Tel

04-2940-8611

Email

cs.thc@oukai.or.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



Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 30 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

Open public recruiting

Date of protocol fixation

2017 Year 03 Month 22 Day

Date of IRB


Anticipated trial start date

2017 Year 03 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 03 Month 29 Day

Last modified on

2023 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030728


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name