Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00401544 | Darbepoetin Alfa With or Without Intravenous (IV) Iron | PHASE2 | COMPLETED | 243 | — | — | Dec 1, 2006 | Mar 1, 2008 | Jan 29, 2014 | - | — |
Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.
Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.
| Arm | Type | Description |
|---|---|---|
| Darbepoetin alfa 300 μg plus IV Iron | EXPERIMENTAL | Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| Darbepoetin alfa 300 μg | EXPERIMENTAL | Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| Darbepoetin alfa 500 μg | EXPERIMENTAL | Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| Darbepoetin alfa 500 μg plus IV Iron | ACTIVE_COMPARATOR | Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| Name | Type | Description |
|---|---|---|
| darbepoetin alfa | DRUG | Darbepoetin alfa administered by subcutaneous injection. |
| IV iron dextran | DRUG | Administered by intravenous (IV) injection. |
Inclusion Criteria: * Active non myeloid malignancy(cies) including lymphocytic leukemias * Received chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy * Anemia due to chemotherapy (screening Hgb \<or = 10.0 g/dL) * at least 18 years of age at screenin...