Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
iron dextran · 1 trial · 2 indications
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...
Iron dextran is used for anemia, specifically in patients with non-myeloid malignancies who have anemia. It is being studied as an add-on to darbepoetin alfa therapy. The drug is currently in Phase 2 clinical development and is considered investigational, meaning it is not yet approved for this use.
Iron dextran is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating anemia in patients with non-myeloid malignancies.
Iron dextran is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, active-controlled study. The drug is still investigational and has not been approved by regulatory authorities for the treatment of anemia.
Iron dextran has been studied in one completed clinical trial, identified as NCT00401544. This Phase 2 trial evaluated darbepoetin alfa with or without intravenous iron in 243 patients with anemia and non-myeloid malignancies. The trial was randomized, double-blind, and active-controlled.
No, iron dextran is not the same as darbepoetin alfa. Iron dextran is an iron supplement, while darbepoetin alfa is an erythropoiesis-stimulating agent. In the clinical trial NCT00401544, iron dextran was studied as an add-on to darbepoetin alfa to treat anemia in patients with non-myeloid malignancies.