The study of TOpiroxostat for Possible benefits

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000023568
• Date of registration: 09/08/2016
• Prospective Registration: Yes
• Primary sponsor: Toho University Medical Center Sakura Hospital
• Public title: The study of TOpiroxostat for Possible benefits
• Scientific title: The study of TOpiroxostat for Possible benefits - The study of TOpiroxostat for Possible benefits (TOP-A Study)
• Date of first enrolment: 2016/09/01
• Target sample size: 30
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027143
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Hiroki Takayama
• Affiliation: Soiken Inc. Clinical Study Support Division

• Name: Ichiro Tatsuno
• Affiliation: Toho University Medical Center Sakura Hospital Center of Diabetes, Endocrinology and Metabolism

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 50years-old
Age maximum: 80years-old
Gender: Male

Health Condition(s) or Problem(s) studied

Hyperuricemia complicated with diabetes

Intervention(s)

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.

Primary Outcome(s)

1. Amount of change in CAVI at the week 24 2. Amount and percent change in blood XOR activity at the 24 week

Secondary Outcome(s)

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

Source(s) of Monetary Support

SANWA KAGAKU KENKYUSHO CO. LTD.

Ethics review

Status: YES
Approval date:
Contact: