Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Epoetin Hospira Arm
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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