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This is a prospective, double-blind, randomized, placebo-controlled study to assess the effects of suramin as a potential treatment option to prevent subjects with AKI from progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III or dialysis dependent AKI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suramin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suramin | Drug | Suramin is administered via IV infusion as a single dose of 3 mg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI | The difference between the effect of a 3.0 mg/kg infusion of suramin versus placebo will be based on meeting 2 or more of the composite event endpoints of: peak serum creatinine (Cr) of 6 mg/dL or above from investigational product (IP) infusion through Day or progression to KDIGO Stage III within 72 hours (hr) from IP infusion or death or dialysis from IP infusion through Day 7. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas Medical Sciences (UAMS) | Little Rock | Arkansas | 72205 | United States | ||
| California Institute of Renal Research |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D013498 | Suramin |
| ID | Term |
|---|---|
| D009282 | Naphthalenesulfonates |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo |
| Drug |
Placebo |
|
| La Mesa |
| California |
| 91942 |
| United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 900953 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30303 | United States |
| Emory Johns Creek Hospital | Johns Creek | Georgia | 30097 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| University of Missouri - Dept. of Surgery | Columbia | Missouri | 65212 | United States |
| University of New Mexico Health Science Center | Albuquerque | New Mexico | 87131 | United States |
| New York-Presbyterian Medical Center of Queens | Flushing | New York | 11355 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157-1009 | United States |
| Southeast Renal Research Institute | Chattanooga | Tennessee | 37404 | United States |
| Baylor Scott and White Research Institute - Dallas Clinical Trials Office | Dallas | Texas | 75246 | United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011083 | Polycyclic Compounds |