Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Epoetin
epoetin alfa or beta · 4 trials · 1 indication
A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.
A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| RO0503821 (1x/2 Weeks) | EXPERIMENTAL | Eligible participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 international units (IU)/week, administered during the week preceding the switch to the study drug. |
| RO0503821 (1x/4 Weeks) | EXPERIMENTAL | Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug. |
| Epoetin Reference | ACTIVE_COMPARATOR | Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks . |
| Epoetin (1-3x/Weeks) | ACTIVE_COMPARATOR | Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks. |
| Name | Type | Description |
|---|---|---|
| epoetin alfa or beta | DRUG | iv or sc, as prescribed |
| methoxy polyethylene glycol-epoetin beta [Mircera] | DRUG | 30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks |
| methoxy polyethylene glycol-epoetin beta (Mircera) | DRUG | 60, 100 or 180 micrograms sc (starting dose) every 2 weeks |
| RO0503821 (1x/2 Weeks) | DRUG | 60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks. |
| RO0503821 (1x/4 Weeks) | DRUG | 120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks. |
| epoetin | DRUG | 3 times a week iv, as prescribed. |
Inclusion Criteria: * adult patients \>=18 years of age; * chronic renal anemia; * on dialysis therapy for at least 12 weeks before screening; * receiving iv or sc epoetin for at least 8 weeks before screening. Exclusion Criteria: * women who are pregnant, breastfeeding or using unreliable birth ...
| 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 |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE2 | HEC53856, rHuEPO |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
Epoetin alfa or beta is used for the treatment of anemia, including anemia in dialysis patients. It is a Phase 3 therapy in the hematology area developed by Roche Holding AG. The clinical program studied its use in adults 18 years and older with anemia.
Epoetin alfa or beta targets EPOR, the erythropoietin receptor, and acts as an agonist at that receptor. By binding and activating EPOR, it stimulates erythropoiesis, the production of red blood cells, which is the basis for its use in anemia.
Epoetin alfa or beta is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor behind the Phase 3 clinical program evaluating the drug in anemia, including studies conducted in dialysis patients across multiple countries.
Epoetin alfa or beta is in Phase 3 development for anemia. Three Phase 3 trials have been completed, and none are currently active. The drug is investigational and is not described as approved for any indication.
Three completed Phase 3 trials studied epoetin alfa or beta in anemia: NCT00081484 with 336 patients, NCT00077623 with 572 patients, and NCT00077610 with 673 patients. Together they enrolled 1,581 participants, all adults 18 years and older, in active-controlled studies.
Yes, epoetin alfa or beta is also known as Mircera. The Phase 3 trials are titled as studies of intravenous or subcutaneous Mircera for the treatment of anemia in dialysis patients, so searches for Mircera refer to the same Roche asset.