Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as epoetin beta [NeoRecormon]
Epoetin Beta · 6 trials · 1 indication
LVMI (in g/m\^2) = (0.8 \[1.04 {(LVEDD + IVS + PWT)\^3 - (LVEDD)\^3}\] + 0.6) divided by BSA. Here, LVEDD = left ventricular end diastolic diameter (in centimeters \[cm\]); PWT = left ventricular posterior wall thickness in diastole (in cm); IVS = interventricular septal wall thickness in diastole (in cm). Echocardiogram was performed at baseline and Month 15 to interpret LVMI which was expressed in grams per meter square (g/m\^2).
The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization. The time to occurrence of a cardiovascular event was determined as the time from randomization until any of the above listed events whichever occurred first. The first event per participant was used for the analysis. Only events confirmed by the Endpoint Committee were considered for analysis.
Response was defined as increase of hemoglobin levels by at least 2 grams per deciliter (g/dL) as compared to baseline or the achievement of hemoglobin level of 12 g/dL after 12 weeks of treatment in the absence of red blood cells transfusion.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Epoetin beta | EXPERIMENTAL | Participants will receive epoetin beta over an 8-week correction phase and a 4-week extension or continuation phase, for a total exposure of up to 12 weeks. |
| Group 1 (Early Epoetin Beta) | EXPERIMENTAL | Along with their standard treatment participants will receive epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses will be adjusted according to individual participant's Hb level. Standard treatment will be as per investigator discretion. |
| Group 2 (No/Late Epoetin Beta) | ACTIVE_COMPARATOR | Participants will receive their standard treatment for 15 months but no treatment for anemia correction unless Hb level will be less than (\<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level will be \<10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment will be as per investigator discretion. |
| Early Epoetin Beta Therapy | EXPERIMENTAL | Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months. |
| Late Epoetin Beta Therapy | ACTIVE_COMPARATOR | Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to \<10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL. |
| Name | Type | Description |
|---|---|---|
| epoetin beta | DRUG | As prescribed |
| methoxy polyethylene glycol-epoetin beta [Mircera] | DRUG | 120, 200 or 360 micrograms every 4 weeks |
| epoetin beta [NeoRecormon] | DRUG | Participants in the early treatment group immediately started epoetin beta treatment to reach a target Hb level of 13-15 g/dL at the end of the correction phase. |
Inclusion Criteria: * male or female patients, \>=18 years of age; * chronic renal anemia; * Hb concentration 10.0 - 12.0 g/dL during the screening period; * continuous subcutaneous maintenance therapy with epoetin at the same dose AND same dosing interval for at least 12 weeks before and throughou...