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Also known as HX575 epoetin alfa (Sandoz), Binocrit® (Europe), Epoetin alfa HEXAL® (Europe), Abseamed® (Europe), HX575 recombinant human erythropoietin alfa
HX575 epoetin alfa · 2 trials · 3 indications
Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
| Arm | Type | Description |
|---|---|---|
| HX575 epoetin alfa | EXPERIMENTAL | HX575, recombinant human epoetin alfa |
| US-licensed epoetin alfa | ACTIVE_COMPARATOR | US-licensed recombinant human epoetin alfa |
| HX575 epoetin alfa (Sandoz) | EXPERIMENTAL | Single arm |
| Name | Type | Description |
|---|---|---|
| HX575 epoetin alfa | DRUG | Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL. |
| US-licensed epoetin alfa | DRUG | Solution for subcutaneous injection. |
| HX575 epoetin alfa (Sandoz) | DRUG | Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia. |
Inclusion Criteria: * Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous maintenance therapy with Epogen® or Procrit® at least once per week * Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period * Adequate iron substitution Exclusion Criteria:...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | Luspatercept |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Disc Medicine, Inc. | IRON | 2 | PHASE2 | DISC-0974 |
| Akebia Therapeutics, Inc. | AKBA | 2 | PHASE3 | Vadadustat |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
HX575 epoetin alfa is an investigational epoetin alfa product developed by Sandoz, part of Novartis AG (ticker NVS). It is being studied as a biosimilar-style erythropoiesis-stimulating agent for the treatment of anemia associated with chronic kidney disease. It has been evaluated in Phase 3 clinical trials in adults.
HX575 epoetin alfa is being developed to treat anemia in adults with chronic kidney disease. Its Phase 3 program compared it with US-licensed epoetin alfa for safety and efficacy in this patient population, and a separate Phase 3 study evaluated subcutaneous administration in chronic kidney disease patients.
HX575 epoetin alfa is developed by Sandoz, which is part of Novartis AG, listed under the ticker NVS. Novartis is the parent company associated with the asset, and the drug is also referred to as HX575 epoetin alfa (Sandoz).
HX575 epoetin alfa is in Phase 3 development. Its Phase 3 trials have been completed, and no trials are currently listed as active. The program has not been described as FDA approved, so it remains an investigational product rather than an approved therapy.
HX575 epoetin alfa has been studied in two completed Phase 3 trials. NCT01693029 compared its safety and efficacy with US-licensed epoetin alfa in 435 adults with anemia and chronic kidney disease in the United States. NCT01576341 evaluated subcutaneous HX575 epoetin alfa in 417 chronic kidney disease patients across Europe and Turkey.
Yes. HX575 epoetin alfa is also known as HX575 epoetin alfa (Sandoz), reflecting that Sandoz, part of Novartis AG, is the developer. Both names refer to the same investigational epoetin alfa product studied in Phase 3 trials for anemia in chronic kidney disease.