Unique ID issued by UMIN | UMIN000023568 |
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Receipt number | 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 18:24:33 |
The study of TOpiroxostat for Possible benefits
The study of TOpiroxostat for Possible benefits (TOP-A Study)
The study of TOpiroxostat for Possible benefits
The study of TOpiroxostat for Possible benefits (TOP-A Study)
Japan |
Hyperuricemia complicated with diabetes
Endocrinology and Metabolism |
Others
NO
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.
Efficacy
1. Amount of change in CAVI at the week 24
2. Amount and percent change in blood XOR activity at the 24 week
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
50 | years-old | <= |
80 | years-old | > |
Male
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
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
30
1st name | |
Middle name | |
Last name | Ichiro Tatsuno |
Toho University Medical Center Sakura Hospital
Center of Diabetes, Endocrinology and Metabolism
564-1 Shimoshizu, Sakura, Chiba
043-462-8811
ichiro.tatsuno@med.toho-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroki Takayama |
Soiken Inc.
Clinical Study Support Division
NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
03-3295-1350
takayama@soiken.com
Toho University Medical Center Sakura Hospital
SANWA KAGAKU KENKYUSHO CO. LTD.
Profit organization
NO
2016 | Year | 08 | Month | 09 | Day |
Unpublished
Completed
2016 | Year | 02 | Month | 04 | Day |
2016 | Year | 09 | Month | 01 | Day |
2016 | Year | 08 | Month | 09 | Day |
2019 | Year | 03 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027143
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