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Also known as Epoetin Hospira Arm, ESA, Erythropoetin Stimulating Agent, Erythropoetin Stimulation Agents
Epoetin Hospira · 6 trials · 4 indications
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
If AUC0-48 cannot be calculated then AUC from time of dose administration to the time of the last measurable concentration (AUC0-t) will be used as the primary measure.
| Arm | Type | Description |
|---|---|---|
| Epoetin Hospira | OTHER | Epoetin Hospira Arm |
| Standard of Care | OTHER | Standard of care arm |
| Epogen (Amgen) | ACTIVE_COMPARATOR | Epogen (Amgen) |
| Arm A: Epoetin Hospira administered IV for three doses | EXPERIMENTAL | - |
| Arm B: Epogen administered IV for three doses | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Epoetin Hospira Arm | BIOLOGICAL | Epoetin Hospira Arm: Epoetin Hospira will be administered intravenously (IV) per the analogous version of the Fresenius Medical Care North America (FMCNA) cMAB 1 (inclusive of version 1.0, 1.1,...)erythropoietin stimulating agents (ESA) dosing algorithm for Epoetin Hospira for 24 weeks. Subjects will have Epoetin Hospira initiated using the same ESA dose level and frequency of administration for Epogen prior to randomization into the trial. Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics. |
| Standard of Care Arm | OTHER | Standard of care arm: No interventions will be performed in this arm for the clinical study; and subjects will receive ongoing standard of care, which includes Epogen administered IV per the FMCNA cMAB 5 (inclusive of versions 5.0, 5.1,....) ESA dosing algorithm and IV iron per the FMCNA protocol that is standard of care, at FMCNA clinics during the contemporaneous 24 week period. |
| IV Iron | DRUG | Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics. |
| Epoetin Hospira | BIOLOGICAL | Intravenous (IV) injection |
| Epogen (Amgen) | BIOLOGICAL | Variable dose |
| Epogen Amgen | BIOLOGICAL | Variable dose |
| Epogen | DRUG | IV dose 3 times a week |
Inclusion Criteria Subjects eligible to be entered into the study will meet all of the following criteria: 1. Adult female or male subjects; age ≥ 18 years. 2. End stage renal disease subjects treated in-center with the modality of hemodialysis for ≥ 120 days. 3. Diagnosed with anemia. 4. Administ...
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Epoetin Hospira is an investigational erythropoiesis-stimulating agent developed by Pfizer, Inc. (NYSE: PFE) for the treatment of anemia associated with chronic kidney disease and chronic renal failure, including patients requiring hemodialysis. It is a monoclonal antibody that acts as an agonist at the erythropoietin receptor (EPOR).
Epoetin Hospira is being studied for the management of anemia in patients with chronic kidney disease, chronic renal failure, and chronic renal failure requiring hemodialysis. Its Phase 3 trials evaluated subcutaneous and intravenous dosing in adults receiving epoetin maintenance treatment.
Epoetin Hospira targets the erythropoietin receptor (EPOR) and functions as an agonist. By activating EPOR, it is designed to stimulate erythropoiesis, the production of red blood cells, which is relevant to treating anemia in chronic kidney disease and chronic renal failure.
Epoetin Hospira is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the Phase 3 clinical program for this erythropoiesis-stimulating agent.
Epoetin Hospira is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 3 program includes completed trials in chronic kidney disease and chronic renal failure requiring hemodialysis.
Epoetin Hospira has been evaluated in completed Phase 3 trials, including NCT02504294, NCT01628120, NCT01628107, and NCT01473420. These studies enrolled adults with chronic kidney disease or chronic renal failure requiring hemodialysis and assessed subcutaneous or intravenous epoetin maintenance treatment.
Yes, Epoetin Hospira Arm is an alternative name for Epoetin Hospira. Both refer to the same investigational erythropoiesis-stimulating agent developed by Pfizer for anemia in chronic kidney disease and chronic renal failure.