Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Iron saccharate · 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...
Iron saccharate is being studied for use in hematological malignancies, specifically in patients undergoing autologous hematopoietic stem cell transplantation. It is an investigational small molecule developed by Amgen Inc. that is currently in Phase 2 clinical development.
Iron saccharate is a small molecule that provides iron supplementation. It is being evaluated for its ability to support erythropoiesis in patients with hematological malignancies following autologous stem cell transplantation.
Iron saccharate is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 2 clinical development for hematological malignancies.
Iron saccharate is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, with no active trials currently ongoing.
Iron saccharate has been studied in one completed Phase 2 clinical trial, NCT00557817, titled 'Erythropoietin (Epo) and Venofer Trial After Autologous Hematopoietic Stem Cell Transplantation (HSCT).' The trial enrolled 125 patients with hematological malignancies in Belgium and was actively controlled.
Iron saccharate is also known as Venofer, as indicated by the clinical trial title. The drug is being developed by Amgen Inc. and is currently in Phase 2 clinical development for hematological malignancies.