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Also known as Darbepoetin alpha (Aranesp)
Darbepoetin alpha · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | NO_INTERVENTION | No medication given |
| 2 | ACTIVE_COMPARATOR | Aranesp 300 µg/15 days |
| 3 | ACTIVE_COMPARATOR | Aranesp 300 µg/15 days. Venofer 200 mg on days 28, 42, and 56 after the transplant. |
| Name | Type | Description |
|---|---|---|
| Darbepoetin alpha (Aranesp) | DRUG | Darbepoetin alpha (Aranesp) will be administered subcutaneously (s.c.) at the dose of 300 µg. The first dose will be given on day 28 and the following doses at 2-week intervals around days 42, 56, 70, 84, 98 and 112 post-transplant. Once the target Hb (13 g/dL) has been attained, the dose of Aranesp will be reduced by half to 150 µg. If the Hb increases to \> 14 g/dL, Aranesp will be withheld and resumed at the dose of 150 µg when the Hb decreases \< 13 g/dL. If the Hb decreases to \< 12 g/dL, the dose of Aranesp will be increased to 300 µg again. |
| Iron saccharate (Venofer) | DRUG | Iron saccharate (Venofer) will be administered intravenously (i.v.) at the dose of 200 mg (2 vials of Venofer) on days 28, 42 and 56 after the transplant. Venofer will be diluted in 250 ml saline and infused over 60 minutes. Iron will be omitted in patients with severe iron overload (serum ferritin \> 2500 µg/L in the absence of inflammation or liver necrosis) or elevated transferrin saturation (TS \> 60%) between days 21 and 56. No iron supplementation will be allowed in arm 1. No iron supplementation will be allowed in arm 2 before day 70 after the transplant. In arms 2 and 3, if patients have evidence of functional iron deficiency (transferrin saturation \< 20%) on day 70 or later, they will receive 300 mg of Venofer over 90 min, for a minimum of 2 doses. |
Inclusion criteria: * Male or female; female patients must use a reliable contraception method * Age \> 16 yrs and \< 70 yrs * No terminal organ failure * Written informed consent given by patient or his/her guardian if of minor age. * Adequate iron stores (serum ferritin \> 100 µg/L) on day 21 pos...
Darbepoetin alpha is being studied in hematological malignancies as a supportive care agent for patients undergoing autologous hematopoietic stem cell transplantation. It is an erythropoiesis-stimulating agent that stimulates red blood cell production. The Phase 2 trial NCT00557817 evaluated it alongside intravenous iron (Venofer) in this setting.
Darbepoetin alpha targets the erythropoietin receptor (EPOR), where it acts as an agonist. By binding to and activating EPOR on erythroid progenitor cells, it stimulates erythropoiesis, the production of red blood cells. This mechanism underlies its use in managing anemia in patients with hematological malignancies undergoing stem cell transplantation.
Darbepoetin alpha is developed and manufactured by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen is a biotechnology company headquartered in Thousand Oaks, California, and markets darbepoetin alpha under the brand name Aranesp.
Darbepoetin alpha is in Phase 2 development for hematological malignancies. One completed Phase 2 trial, NCT00557817, has evaluated the drug in this indication. It is an investigational use in this setting and has not been approved for hematological malignancies.
Darbepoetin alpha has been studied in the completed Phase 2 trial NCT00557817, titled "Erythropoietin (Epo) and Venofer Trial After Autologous Hematopoietic Stem Cell Transplantation (HSCT)." The trial enrolled 125 participants in Belgium, was randomized, active-controlled, and included patients aged 16 years and older with hematological malignancies.
Yes, Darbepoetin alpha is also known by the brand name Aranesp. Aranesp is the proprietary name under which Amgen markets darbepoetin alpha. Both names refer to the same erythropoiesis-stimulating agent that targets the erythropoietin receptor (EPOR).