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Label indication PROCRIT is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ).
Also known as EPO, Epoetin alfa-epbx, Epogen, Eprex, Procrit, Retacrit
Epoetin Alfa · 45 trials · 43 indications
Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.
Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.
| Arm | Type | Description |
|---|---|---|
| Epoetin alfa | EXPERIMENTAL | Group 1: Epoetin alfa type = range unit= IU/Kg number= 337.5 to 1050 IU/Kg form= solution for injection route= subcutaneous use weekly injections (max 40 000 IU per week for first 8 weeks of treatment max 80 000 IU per week later) using pre-filled 1mL 40 000 IU syringes for 24 to 48 weeks |
| No treatment | PLACEBO_COMPARATOR | Group 2: Placebo form= solution for injection route= subcutaneous use weekly injections for 24 to 48 weeks |
| Arm A (lenalidomide) | ACTIVE_COMPARATOR | Patients receive lenalidomide PO QD on days 1-21. Patients undergo bone marrow biopsy at screening and during follow-up. Patients undergo blood specimen collection on study. |
| Arm B (lenalidomide, epoetin alfa) | EXPERIMENTAL | Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly. Patients undergo bone marrow biopsy at screening and during follow-up. Patients undergo blood specimen collection on study. |
| 001 | EXPERIMENTAL | epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks |
| 003 | EXPERIMENTAL | epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk |
| 002 | EXPERIMENTAL | epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks |
| Group 2 | OTHER | Standard treatment of anemia excluding use of erythropoetin stimulating agents (ESAs). |
| Name | Type | Description |
|---|---|---|
| Group 2: Placebo | DRUG | form= solution for injection, route= subcutaneous use, weekly injections for 24 to 48 weeks |
| Group 1: Epoetin alfa | DRUG | type = range, unit= IU/Kg, number= 337.5 to 1050 IU/Kg, form= solution for injection, route= subcutaneous use, weekly injections (max 40,000 IU per week for first 8 weeks of treatment, max 80,000 IU per week later) using pre-filled 1mL 40,000 IU syringes for 24 to 48 weeks |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Epoetin Alfa | BIOLOGICAL | Given SC |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Lenalidomide | DRUG | Given PO |
| Standard supportive care (packed RBC transfusion) | OTHER | Per doctor prescription |
| epoetin alfa + packed RBC transfusion | DRUG | 40,000 IU SC once a week. |
| Standard of care | OTHER | - |
| PROCRIT (Epoetin alfa) | DRUG | - |
Inclusion Criteria: * Diagnosis of MDS according to World Health Organization or French-American-British pathologic classification (confirmed via bone marrow aspirate/biopsy) within 12 weeks prior to screening * Documentation of an International Prognostic Scoring System score indicating Low- or In...
| 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 is used to treat anemia across several settings, including anemia in patients with chronic kidney disease, myelodysplastic syndromes, and anemia related to cancer or chemotherapy. It is also studied in patients with acquired immunodeficiency syndrome and in breast cancer, and in research involving packed red blood cell transfusion.
Epoetin Alfa works as an agonist at the erythropoietin receptor, known as EPOR. By binding and activating EPOR, it stimulates the signaling pathway that drives red blood cell production, which is the mechanism underlying its use in treating anemia.
Epoetin Alfa is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is associated with the drug across its clinical development program in hematology, including studies of the PROCRIT formulation in anemic patients with chronic kidney disease.
Epoetin Alfa is in Phase 2 development. Its clinical program includes 29 trials in total, of which 28 are completed and none are currently active. Individual studies have spanned Phase 1 through Phase 3, with the Phase 3 trials now completed or no longer recruiting.
Epoetin Alfa has been studied in trials including NCT01381809, a Phase 3 efficacy study in anemic patients with myelodysplastic syndromes, and NCT00843882, a Phase 3 study of lenalidomide with or without Epoetin Alfa in myelodysplastic syndrome and anemia. Other trials include NCT00641589 and NCT00446576.