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The purpose of this study is to evaluate the safety and tolerability of two dosing regimens of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria on background angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor antagonist (ARB) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | Placebo |
|
| B | Experimental | FG-3019 5 mg/kg |
|
| C | Experimental | FG-3019 10 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FG-3019 | Drug | Placebo every 2 weeks IV for all infusions |
| |
| FG-3019 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of FG-3019 | 34 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | 34 weeks | |
| Change from baseline in first morning urinary albumin creatinine ratio (ACR) | 6 weeks (10 mg/kg) or 10 weeks (5 mg/kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| Drug |
FG-3019 5 mg/kg every 2 weeks IV for all infusions |
|
| FG-3019 | Drug | FG-3019 10 mg/kg IV for infusions on Days 1, 15, 29 and 57 and Placebo IV on Days 43 and 71 |
|
| Tempe |
| Arizona |
| United States |
| La Mesa | California | United States |
| Torrance | California | United States |
| Kissimmee | Florida | United States |
| Atlanta | Georgia | United States |
| Springfield | Massachusetts | United States |
| Omaha | Nebraska | United States |
| Flushing | New York | United States |
| New York | New York | United States |
| Chapel Hill | North Carolina | United States |
| Cleveland | Ohio | United States |
| Portland | Oregon | United States |
| Hershey | Pennsylvania | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Fairfax | Virginia | United States |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003928 | Diabetic Nephropathies |
| D003924 | Diabetes Mellitus, Type 2 |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| 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 |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C560078 | pamrevlumab |
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