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| Name | Class |
|---|---|
| Fuji Yakuhin Co., Ltd. | INDUSTRY |
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The purpose of this study is to investigate the effect of topiroxostat on urinary albumin excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia with or without gout. Participants are randomized to placebo (n=20) or topiroxostat (n=40) for 28 weeks. The investigational drugs for this study are supplied by FUJI YAKUHIN CO., LTD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active comparator | Active Comparator | Topiroxostat, (Oral daily dosing for 28 weeks) |
|
| Placebo comparator | Placebo Comparator | Placebo, (Oral daily dosing for 28 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiroxostat BID, (Oral daily dosing for 28 weeks) | Drug | The dose of topiroxostat is increased up to 160 mg/day in a stepwise manner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in urine albumin creatinine ratio | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC | 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanwa Kagaku Kenkyusho Co., Ltd. | Nagoya | Aichi-ken | 461-8631 | Japan |
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| Placebo BID, (Oral daily dosing for 28 weeks) | Drug | Subjects randomized to the placebo arm will receive placebo. |
|
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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