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The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for patients with diabetic nephropathy.
The secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | Placebo |
|
| B | Active Comparator | 250mg active ingredient |
|
| C | Active Comparator | 500mg active ingredient |
|
| D | Active Comparator | 1000mg active ingredient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PH3 | Drug | Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Albumin/Creatinine Ratio (UACR) | Change in urinary albumin/creatinine ratio (UACR) from baseline to Week 24 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Urine Albumin | Change in urine albumin level from baseline to Week 24 | 24 weeks |
| Serum Creatinine | Change in serum creatinine level from baseline to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wu Chang Yang, MD | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Yi-Jen Hung, MD | Tri-Service General Hospital (TSGH) | Principal Investigator |
| Huey-Herng Sheu, MD, PhD | Taichung Veterans General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan | |||
| Tri-Service General Hospital |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 24 weeks |
| Estimated Glomerular Filtration Rate (eGFR) | Change in estimated glomerular filtration rate (eGFR) from baseline to Week 24 | 24 weeks |
| HbA1c | Change in HbA1c from baseline to Week 24 | 24 weeks |
| Taipei |
| 114 |
| Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |