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This is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Normal Renal Function | Experimental | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
|
| Cohort 2: Mild Renal Impairment | Experimental | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
|
| Cohort 3: Moderate Renal Impairment | Experimental | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
|
| Cohort 4: Severe Renal Impairment | Experimental | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
|
| Cohort 5: End Stage Renal Disease | Experimental | Vepoloxamer Injection, 50 mg/kg for 1 hour followed by 15 mg/kg/hr for 5 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vepoloxamer | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics variable - Area under the plasma concentration curve | Time zero through 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03 | Time zero through Day 14 |
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Key Inclusion Criteria:
Key Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Edwin L Parsley, DO | Mast Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Lakewood | Colorado | 80228 | United States | ||
| DaVita Clinical Research |
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| Minneapolis |
| Minnesota |
| 55404 |
| United States |