Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PROCRIT
Epoetin alfa 3 times weekly/once weekly · 2 trials · 1 indication
The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.
| Arm | Type | Description |
|---|---|---|
| TIW: Epoetin alfa 3 injections Weekly/Once Weekly | EXPERIMENTAL | Participants will be administered with epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU) |
| QW: Epoetin alfa once weekly | EXPERIMENTAL | Participants will be administered with epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU). |
| Q2W: Epoetin alfa once every two weeks | EXPERIMENTAL | Participants will be administered with epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU). |
| Name | Type | Description |
|---|---|---|
| Epoetin alfa 3 times weekly /once weekly | DRUG | Epoetin alfa will be administered as a SC injections at initial dose of 50 IU/kg (3 times weekly for 22 weeks) and at initial dose of 10000 IU (once weekly for 22 weeks) |
| Epoetin alfa once weekly | DRUG | Epoetin alfa will be administered as a SC injection at initial dose of 10000 IU (once weekly for 44 weeks). |
| Epoetin alfa once every two weeks | DRUG | Epoetin alfa will be administered as a SC injection at initial dose of 20000 IU (once every 2 weeks for 44 weeks). |
| PROCRIT (Epoetin alfa) | DRUG | - |
Inclusion Criteria: * Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) more than or equal to 15 mL/min per 1.73 m2 and less than 60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory * Require support of an erythropoieti...
| 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 3 times weekly/once weekly is used for the initiation and maintenance treatment of anemia associated with chronic kidney disease. It is a hematology therapy developed by Johnson & Johnson and studied in adults 18 years and older.
Epoetin alfa 3 times weekly/once weekly acts as an agonist at EPOR, the erythropoietin receptor. By activating this receptor, the drug stimulates red blood cell production, which is the basis for its use in treating anemia associated with chronic kidney disease.
Epoetin alfa 3 times weekly/once weekly is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 3 study of the drug in anemia associated with chronic kidney disease.
Epoetin alfa 3 times weekly/once weekly is in Phase 3 development. It is an investigational therapy, and the Phase 3 trial evaluating it for anemia associated with chronic kidney disease has been completed.
Epoetin alfa 3 times weekly/once weekly was studied in the Phase 3 trial NCT00440557, titled An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease. The completed trial enrolled 375 adults in the United States and Puerto Rico.