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The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VPI-2690B low dose | Active Comparator | 6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks |
|
| VPI-2690B medium dose | Active Comparator | 18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks |
|
| Placebo | Placebo Comparator | 6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks |
|
| VPI-2690B high dose | Active Comparator | 48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VPI-2690B low dose | Drug | Comparison of different doses of study drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in albuminuria | 50 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in eGFR | 50 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vascular Pharmaceuticals Inc Clinical Trial | Vascular Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| VPI-2690B medium dose |
| Drug |
Comparison of different doses of study drug |
|
| Placebo to match VPI-2690B | Drug |
|
| VPI-2690B high dose | Drug | Comparison of different doses of study drug |
|
| Little Rock |
| Arkansas |
| United States |
| La Mesa | California | United States |
| Riverside | California | United States |
| Sacramento | California | United States |
| Tustin | California | United States |
| Cooper City | Florida | United States |
| Coral Springs | Florida | United States |
| Hialeah | Florida | United States |
| Miami | Florida | United States |
| St. Petersburg | Florida | United States |
| Winter Park | Florida | United States |
| Columbus | Georgia | United States |
| Idaho Falls | Idaho | United States |
| Mount Prospect | Illinois | United States |
| Peoria | Illinois | United States |
| Merrillville | Indiana | United States |
| Boston | Massachusetts | United States |
| Flint | Michigan | United States |
| Kansas City | Missouri | United States |
| Las Vegas | Nevada | United States |
| Albany | New York | United States |
| Asheville | North Carolina | United States |
| Greenville | North Carolina | United States |
| Morehead City | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Wooster | Ohio | United States |
| Allentown | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| El Paso | Texas | United States |
| San Antonio | Texas | United States |
| Ponce | Puerto Rico |
| San Juan | Puerto Rico |
| 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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