UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects on cardiac, renal, and vascular endothelial markers after switching to topiroxostat from febuxostat treatment among IGT patients
Title of the study (Brief title)	Effects on cardiac, renal, and vascular endothelial markers after switching to topiroxostat from febuxostat treatment among IGT patients
Region	Japan

Condition
Condition	Hyperuricemic patients complicated with impaired glucose tolerance (IGT)
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of swithing febuxostat to a xanthine oxidase inhibitor, topiroxostat treatment on cardiac, renal, and vascular endothelial markers among hyperuricemic patients complicated with impaired glucose tolerance (IGT) through an exploratory study
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. change of L-FABP value 2. change of UACR value 3. change of serum uric acid value 4. change of BNP value 5. change of eGFR value 6. change of HbA1c value 7. change of HOMA-IR value 8. change of hsCRP value 9. amount of change in plasma XOR activity 10. rate of urarthritis (side effect) 11. rate of abnormal test results of liver function (side effect) 12. rate of other adverse events
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1. Study period: 4 weeks before intervention + interventional treatment for 24 weeks 2. Prescription of topiroxostat is based on the amount of febuxostat administered 3. Amount of topiroxostat is increased or decreased to reach the target serum uric acid value >=4.0mg/dL, and <=6.0 mg/dL 4. Maximum amount of topiroxostat administration is 80mg x 2, and the minimum amount is 20mg x 1
Interventions/Control_2
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	Patients who meet all of the following criteria are included: 1. Being diagnosed as having urarthritis or hyperuricemia at the time of giving their consent 2. Have treated urarthritis or hyperuricemia with topiroxostat for 12 weeks or longer until giving their written consent form 3. Diagnosed as IGT, and currently on drug treatment 4. Have continued diet and exercise therapy for at least 8 weeks until giving written consent form 5. Can provide written consent form by patients themselves 6. Outpatients (who have no plan to be admitted into the hospital)
Key exclusion criteria	Patients who fall into any of the following conditions are excluded: 1. Have a history of hypersensitiveness to topiroxostat, febuxostat, or allopurinol 2. Currently on mercaptopurine hydrate (including those who plan to use) 3. Currently on azathioprine (including those who plan to use) 4. Cancer-carrying (excepts for those completely cured) 5. ALT or AST value is twice higher than the standard value set by each institution 6. Complicated with chronic hepatitis (type B or C) and classified as active 7. Complicated with hepatic cirrhosis 8. Other conditions that may be judged by a (responsible) investigator to be inappropriate to this study
Target sample size	100

Research contact person
Name of lead principal investigator	Osamu Tomonaga
Organization	Diabetes and Lifestyle Center, Tomonaga Clinic
Division name	Internal Medicine
Address	Shinyon curumu building 9F, 4-2-23, Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL	03-3351-0032
Email	boss@tomonaga-clinic.com

Public contact
Name of contact person	Osamu Tomonaga
Organization	Diabetes and Lifestyle Center, Tomonaga Clinic
Division name	Internal Medicine
Address	Shinyon curumu building 9F, 4-2-23, Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL	03-3351-0032
Homepage URL
Email	boss@tomonaga-clinic.com

Sponsor
Institute	Diabetes and Lifestyle Center, Tomonaga Clinic
Institute
Department

Funding Source
Organization	Sanwa Kagaku Kenkyusho Co., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	医療法人社団ライフスタイル　ともながクリニック糖尿病・生活習慣病センター（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 15 Day
Anticipated trial start date	2015 Year 07 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 30 Day
Last modified on	2017 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021006