UMIN-CTR Clinical Trial

Public title

Effects on cardiac, renal, and vascular endothelial markers after switching to topiroxostat from febuxostat treatment among IGT patients

Acronym

Effects on cardiac, renal, and vascular endothelial markers after switching to topiroxostat from febuxostat treatment among IGT patients

Scientific Title

Effects on cardiac, renal, and vascular endothelial markers after switching to topiroxostat from febuxostat treatment among IGT patients

Scientific Title:Acronym

Effects on cardiac, renal, and vascular endothelial markers after switching to topiroxostat from febuxostat treatment among IGT patients

Region

Japan

Condition

Hyperuricemic patients complicated with impaired glucose tolerance (IGT)

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Osamu Tomonaga

Organization

Diabetes and Lifestyle Center, Tomonaga Clinic

Division name

Internal Medicine

Zip code

Address

Shinyon curumu building 9F, 4-2-23, Shinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-3351-0032

Email

boss@tomonaga-clinic.com

Name of contact person

1st name
Middle name
Last name	Osamu Tomonaga

Organization

Diabetes and Lifestyle Center, Tomonaga Clinic

Division name

Internal Medicine

Zip code

Address

Shinyon curumu building 9F, 4-2-23, Shinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-3351-0032

Homepage URL

Email

boss@tomonaga-clinic.com

Institute

Diabetes and Lifestyle Center, Tomonaga Clinic

Institute

Department

Personal name

Organization

Sanwa Kagaku Kenkyusho Co., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2015

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

05

Month

15

Day

Date of IRB

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

Other related information

Registered date

2015

Year

06

Month

30

Day

Last modified on

2017

Year

07

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021006