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| ID | Type | Description | Link |
|---|---|---|---|
| P-Monofer-PK-CKD-03 |
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The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of MonoferĀ® in patients suffering from Non-dialysis Dependent Chronic Kidney Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MonoferĀ® 500 mg | Active Comparator | 500 mg iron isomaltoside 1000 |
|
| MonoferĀ® 1000 mg | Active Comparator | 1000 mg iron isomaltoside 1000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron isomaltoside 1000 | Drug | Single dose of 500 mg administered as a bolus undiluted over 2 min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total serum iron pharmakokinetic parameters | 30min, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Iron isomaltoside 1000 | Drug | Single dose of 1000 mg infused over 15 min. The infusion is diluted in 100mL 0,9% sodium chloride |
|
| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
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