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This is an open-label, multicenter pharmacokinetic study of Hemodialysis (HD) or Peritoneal Dialysis (PD) patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.
This is an open-label, multicenter pharmacokinetic study of HD of adolescent PD patients receiving erythropoietin. Patients between the ages of 12 and 18 were administered 100mg of iron sucrose, undiluted by slow IV push over 5 minutes, and underwent serial blood draws. The patients were subsequently followed for 7 days for safety endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron Sucrose | Experimental | A single 100 mg dose (1 vial), 20 mg/min injected over 5 minutes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Sucrose injection | Drug | Iron sucrose 100 mg dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Plasma Concentration (Cmax) | Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. | 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes |
| Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t) | The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUC 0-t is defined as AUC from time 0 to the last data point | 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes |
| Area Under the Curve From Time Zero Extrapolated to Infinity (AUC 0-∞) | The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC 0-∞ is defined as area under the concentration vs. time curve from zero to infinity. | 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes |
| Terminal Elimination Half-life (T1/2) | T1/2 refers to the time taken for concentration of a drug to decrease from its maximum concentration to half of Cmax | 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Total Body Clearance (CL) | CL refers to the Dose/AUC 0-∞ | 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes |
| Volume of Distribution (Vd) | Vd refers to the ratio of amount of drug in a body (dose) to concentration of the drug that is measured in blood, plasma, and un-bound in interstitial fluid. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Falone, MD | American Regent, Inc. | Study Director |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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| 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |