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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023568
Receipt No. R000027143
Scientific Title The study of TOpiroxostat for Possible benefits
Date of disclosure of the study information 2016/08/09
Last modified on 2019/03/04

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Basic information
Public title The study of TOpiroxostat for Possible benefits
Acronym The study of TOpiroxostat for Possible benefits (TOP-A Study)
Scientific Title The study of TOpiroxostat for Possible benefits
Scientific Title:Acronym The study of TOpiroxostat for Possible benefits (TOP-A Study)
Region
Japan

Condition
Condition Hyperuricemia complicated with diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Using CAVI for measuring the effects on arteriosclerosis among hyperuricemic patients with diabetes who are administered with topiroxostat is examined. Also, blood XOR activity and serum uric acid are measured to examine the relations to arteriosclerosis and medications.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Amount of change in CAVI at the week 24
2. Amount and percent change in blood XOR activity at the 24 week
Key secondary outcomes 1. Index for hyperuricemia: amount of changes in serum uric acid levels , and the amount and percent changes of blood XOR activity
2. Index for arteriosclerosis: changes in CAVI and hsCRP values
3. Index for renal function: change in eGFR, and the amount and rate of changes in ACR (urine albumin/Cr ratio)
4. Index for acid stress: changes in d-ROM, and MDA-LDL
5. Changes in general blood and urine tests items, body weight, BMI, blood pressure, and pulse
6. All measured raw data listed above
7. Incidence rate of abnormality found in liver function tests
8. Frequencies of the occurrence of gouty arthritis attack during the study
9. Correlation between CAVI and blood XOR activity

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 Topiroxosta:
Topiroxostat is orally taken twice a day after breakfast and supper for 24 weeks. At every observation point, patients visit hospital without taking and test are performed. Responsible investigator and investigators change dose of topiroxostat accordingly to the results of the tests.

Topiroxostat is gradually increased by 40 mg/day every 6 weeks starting from 40 mg/day if a serum uric acid level doesn't fall below 3.0 m/dL. If a serum urine acid level becomes< 3.0 m/dL, the amount of topiroxostat is back to the previous amount.

However, whenever gouty arthritis is admitted during the study, the investigator may stop increasing the amount or suspend the administration of topiroxostat until the symptom disappears.
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male
Key inclusion criteria Patients who meet all of the following criteria are included in this study.
1. Male with hyperuricemia
2. Patients aged at 50 years or older, and younger than 80 years at the time of giving their consent
3. Type 2 diabetic patients with HbA1c lower than 9.0% during the last 12 weeks from the consent
4. Patients who are with a uric acid level 7.0 mg/dL or higher and without any medication for hyperuricemia, or hyperuricemic patients who are currently using benzbromarone
5. Patients with ability of giving their written consent
Key exclusion criteria Patients who fall into any of the following criteria are excluded from participating in the study.
1. Female
2. Patients complicated with arteriosclerosis obliterans, or ABI 0.9 or lower
3. Complicated with atrial fibrillation
4. Using any type of insulin treatment
5. Using any type of SGLT2 inhibitors
6. Patients with gouty arthritis at baseline
7. Patients who may show hypersensitiveness to topiroxostat
8. Patients who are currently on mercaptopurine hydrate or azathioprine, or planning to take one of them
9. Patients with liver function failure or cirrhosis of the liver
10. Patients complicated with chronic liver hepatitis (type B, or C), and classified as active hepatitis
11. Patients with kidney stone, or severe renal function failure
12. Patients with malignant tumor (excluding those completely cured)
13. Other conditions that investigators judge to be inappropriate to join the study

Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Tatsuno
Organization Toho University Medical Center Sakura Hospital
Division name Center of Diabetes, Endocrinology and Metabolism
Zip code
Address 564-1 Shimoshizu, Sakura, Chiba
TEL 043-462-8811
Email ichiro.tatsuno@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
Address NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL 03-3295-1350
Homepage URL
Email takayama@soiken.com

Sponsor
Institute Toho University Medical Center Sakura Hospital
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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 09 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 Completed
Date of protocol fixation
2016 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 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
2016 Year 08 Month 09 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027143

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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