A Phase 3 interventional study of epoetin beta [NeoRecormon] and epoetin beta [NeoRecormon] in Anemia, sponsored by Hoffmann-La Roche. Completed at 93 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-29.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 605 is above the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: epoetin beta [NeoRecormon]
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.
Drug: epoetin beta [NeoRecormon]
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.
Participants in the late treatment Group started epoetin beta treatment once a decline in Hb level to \<10.5 g/dL had occurred.
Median Time to First Cardiovascular Event
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.
Time frame: Up to 4 years
Median Time to Death Due to Cardiovascular Events
Time to death due to cardiovascular events is the time determined between randomization and death due to cardiovascular events.
Time frame: Up to 4 years
Number of Participants Who Died Due to Cardiovascular Events
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.
Time frame: Up to 4 years
Median Time to Death Due to All Causes
Time to death due to all causes is the time determined between randomization and death due to all causes.
Time frame: Up to 4 years
Number of Participants Who Died Due to All Causes
Number of participants who died due to all causes are presented in table below.
Time frame: Up to 4 years
Number of Participants Experiencing Worsening of New York Heart Association (NYHA) Class (CL) of Chronic Heart Failure From Baseline (BL)
The NYHA functional classification assesses the severity of symptoms of chronic heart failure and is comprised of four classes. Class I is defined as no limitation of physical activity, Class II is defined as slight limitation of physical activity, Class III is defined as marked limitation of physical activity, and Class IV is defined as unable to carry on any physical activity without discomfort. Shifts of participants from CL 0, CL I, CL II, CL III, CL IV at Baseline (Day 1) to CL 0, CL I, CL II, CL III, CL IV during the study period was determined and presented.
Time frame: Up to 4 years
Median Time to First Cardiovascular Intervention
Time to first cardiovascular intervention is the time between randomization and first intervention determined for all cardiovascular interventions after randomization. Cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation.
Time frame: Up to 4 years
Total Number of Cardiovascular Intervention
Cardiovascular intervention was defined by a clinical review of all concomitant treatments. The cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation. The total number of cardiovascular intervention was determined and presented by each cohort.
Time frame: Up to 4 years
Median Time to First Hospitalization Due to Cardiovascular Events
Time to first hospitalization due to cardiovascular events is defined as the time determined between randomization and first hospitalization due to cardiovascular events.
Time frame: Up to 4 years
Duration of Hospitalization for Cardiovascular Events
The duration of hospitalization was the total number of days that a participant was hospitalized due to cardiovascular events. Participants with no hospitalization were excluded from analysis.
Time frame: Up to 4 years
Mean Change From Baseline in Left Ventricular Mass Index (LVMI)
LVMI is determined by echocardiogram. LVMI indexed to body surface area (gram/square meter) estimated by LV cavity dimension and wall thickness at end-diastole. The change was calculated as week value minus baseline value.
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) and Fractional Myocardial Shortening (FS)
LVEF is a marker of left ventricular systolic function and determined by echocardiogram. It is expressed as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage. FS is used as an estimate of myocardial contractility and determined by echocardiogram and measures as a percentage. The change for LVEF and FS was calculated as Week value minus baseline value.
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Mean Change From Baseline in Left Ventricular Volume (LV Volume )
Left Ventricular Volume is the estimated of left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) determined by Echocardiogram. The change was calculated as week value minus baseline value.
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Mean Values of Echocardiography Parameters
Mean values of Echocardiography (ECHO) Parameters: Left Ventricular End Diastolic Diameter (LVEDD), Left Ventricular Posterior Wall Thickness (LVPWT), IV Septal Wall Thickness (IVSWT), LV End Systolic Diameter (LVESD), LV Relative wall thickness (LVRWT) at Baseline, Year 1, Year 2, Year 3 and Year 4 were presented.
Time frame: Baseline, Year 1, Year 2, Year 3, and Year 4
Mean Values of Body Surface Area
The body surface area (BSA) was determined by Echocardiogram. Absolute mean values of Echocardiography (ECHO) Parameter: Body surface area (BSA) at Baseline, Year 1, Year 2, Year 3 and Year 4 were calculated and presented.
Time frame: Baseline, Year 1, Year 2, Year 3, and Year 4.
Mean Change From Baseline in the Scores of Each of The Eight Health Scales of Quality of Life Based on Short Form-36 (SF-36) Questionnaire
The Quality of life was assessed on the basis of a change from baseline in the scores of each of the eight health scales in the SF-36 questionnaire. The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well-being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health (GH), vitality, mental health. The score for a section is an average of the individual question scores, which are scaled from 0 (worst level of functioning) to 100 (100=best level of functioning). The least squares mean (LSM) change from baseline was determined by Analysis of covariance (ANCOVA) model and presented for each of the eight health scale.
Time frame: Baseline, Year 1, and Year 2
Number of Participants on Blood Pressure/Anti-Hypertensive Treatment According to Class Of Drugs
Anti-hypertensive is defined as class of drugs that are used to treat hypertension. Numbers (No.) of participants treated with at least one hypertensive medication/Treatment (Tt) according to class of drugs were reported.
Time frame: Up to 4 years
Number of Participants With Marked Laboratory Abnormalities
Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Values above and below the given reference range were determined as High or Low range values of the laboratory parameter. Roche's standard reference ranges for laboratory test parameters were used for the analysis. The laboratory parameters with marked abnormality are platelets (reference range is 150-350 10\^9 cells/liter \[L\]), creatinine (reference range is 0-133 micromole per liter), albumin (reference range is 35.0-55 g/L), phosphate (reference range is 0.84-1.45 millimole per liter \[mmol /L\]) and potassium (reference range is 3.4-4.8 mmol /L).
Time frame: Baseline, every 3 months up to 4 years
This study was conducted from 26 July 2000 to 13 December 2004 at 94 centers in 21 countries.
| Milestone | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Started | 301 | 302 |
| Completed | 226 | 250 |
| Not completed | 75 | 52 |
| Withdrew: Adverse event | 17 | 10 |
| Withdrew: Death | 21 | 17 |
| Withdrew: Insufficient therapeutic response | 1 | 0 |
| Withdrew: Violation of selection criteria at entry | 1 | 1 |
| Withdrew: Refused treatment | 23 | 14 |
| Withdrew: Other protocol violation | 2 | 3 |
| Withdrew: Failure to return | 3 | 1 |
| Withdrew: Other withdrawal reason | 7 | 6 |
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.
| days | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Median Time to First Cardiovascular Event | NA (NA to NA) | NA (NA to NA) |
Time to death due to cardiovascular events is the time determined between randomization and death due to cardiovascular events.
| days | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Median Time to Death Due to Cardiovascular Events | NA (NA to NA) | NA (NA to NA) |
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.
| participants | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Total Cardiovascular Death Events | 8 | 6 |
| Cardiac Failure | 1 | 2 |
| Cardiac Failure Acute | 1 | 2 |
| Acute Myocardial Infarction | 1 | 1 |
| Angina Pectoris | 1 | 0 |
| Arrhythmia | 1 | 0 |
| Cardiac Arrest | 1 | 0 |
| Cardio-Respiratory Arrest | 1 | 0 |
| Cardiopulmonary Failure | 1 | 0 |
| Myocardial Infarction | 0 | 1 |
Time to death due to all causes is the time determined between randomization and death due to all causes.
| days | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Median Time to Death Due to All Causes | NA (NA to NA) | NA (NA to NA) |
Number of participants who died due to all causes are presented in table below.
| participants | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Total Death Events for All-cause | 31 | 21 |
| Sudden Death | 4 | 2 |
| Cerebrovascular Accident | 2 | 2 |
| Cardiac Failure | 1 | 2 |
| Cardiac Failure Acute | 1 | 2 |
| Sepsis | 1 | 2 |
| Acute Myocardial Infarction | 1 | 1 |
| Bronchopneumonia | 1 | 1 |
| Respiratory Failure | 1 | 1 |
| Septic Shock | 2 | 0 |
| Acute Heart Failure | 1 | 0 |
| Acute Respiratory Failure | 0 | 1 |
| Angina Pectoris | 1 | 0 |
| Arrhythmia | 1 | 0 |
| Cardiac Arrest | 1 | 0 |
| Cardio-Respiratory Arrest | 1 | 0 |
| Cardiopulmonary Failure | 1 | 0 |
| Cerebral Infarction | 1 | 0 |
| Clostridial Infection | 1 | 0 |
| Colon Cancer Metastatic | 0 | 1 |
| Embolic Stroke | 1 | 0 |
| Intestinal Infarction | 0 | 1 |
| Intestinal Ischaemia | 0 | 1 |
| Laryngeal Cancer | 1 | 0 |
| Lung Neoplasm Malignant | 0 | 1 |
| Metastases To Lung | 1 | 0 |
| Metastatic Neoplasm | 1 | 0 |
| Myocardial Infarction | 0 | 1 |
| Oesophageal Carcinoma | 1 | 0 |
| Peripheral Vascular Disorder | 1 | 0 |
| Pneumonia | 0 | 1 |
| Pulmonary Embolism | 0 | 1 |
| Renal Failure | 1 | 0 |
| Unevaluable Event | 1 | 0 |
| Uraemic Encephalopathy | 1 | 0 |
The NYHA functional classification assesses the severity of symptoms of chronic heart failure and is comprised of four classes. Class I is defined as no limitation of physical activity, Class II is defined as slight limitation of physical activity, Class III is defined as marked limitation of physical activity, and Class IV is defined as unable to carry on any physical activity without discomfort. Shifts of participants from CL 0, CL I, CL II, CL III, CL IV at Baseline (Day 1) to CL 0, CL I, CL II, CL III, CL IV during the study period was determined and presented.
| participants | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| From CL 0 (BL) to CL 0; n = 167, 149 | 49 | 42 |
| From CL 0 (BL) to CL I; n = 167, 149 | 7 | 4 |
| From CL 0 (BL) to CL II; n = 167, 149 | 7 | 7 |
| From CL 0 (BL) to CL III; n = 167, 149 | 2 | 1 |
| From CL 0 (BL) to CL IV; n = 167, 149 | 0 | 0 |
| From CL I (BL) to CL 0; n = 37, 43 | 1 | 0 |
| From CL I (BL) to CL I; n = 37, 43 | 28 | 34 |
| From CL I (BL) to CL II; n = 37, 43 | 5 | 4 |
| From CL I (BL) to CL III; n = 37, 43 | 0 | 0 |
| From CL I (BL) to CL IV; n = 37, 43 | 0 | 0 |
| From CL II (BL) to CL 0; n = 53, 44 | 0 | 0 |
| From CL II (BL) to CL I; n = 53, 44 | 5 | 1 |
| From CL II (BL) to CL II; n = 53, 44 | 39 | 37 |
| From CL II (BL) to CL III; n = 53, 44 | 2 | 4 |
| From CL II (BL) to CL IV; n = 53, 44 | 0 | 0 |
| From CL III (BL) to CL 0; n = 0, 0 | 0 | 0 |
| From CL III (BL)to CL I; n = 0, 0 | 0 | 0 |
| From CL III (BL)to CL II; n = 0, 0 | 0 | 0 |
| From CL III (BL)to CL III; n = 0, 0 | 0 | 0 |
| From CL III (BL)to CL IV; n = 0, 0 | 0 | 0 |
| From CL IV (BL)to CL 0; n = 0, 0 | 0 | 0 |
| From CL IV (BL)to CL I; n = 0, 0 | 0 | 0 |
| From CL IV (BL)to CL II; n = 0, 0 | 0 | 0 |
| From CL IV (BL)to CL III; n = 0, 0 | 0 | 0 |
| From CL IV (BL)to CL IV; n = 0, 0 | 0 | 0 |
Time to first cardiovascular intervention is the time between randomization and first intervention determined for all cardiovascular interventions after randomization. Cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation.
| days | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Median Time to First Cardiovascular Intervention | NA (NA to NA) | NA (NA to NA) |
Cardiovascular intervention was defined by a clinical review of all concomitant treatments. The cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation. The total number of cardiovascular intervention was determined and presented by each cohort.
| number of cardiovascular intervention | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Total Number of Cardiovascular Intervention | 21 | 18 |
Time to first hospitalization due to cardiovascular events is defined as the time determined between randomization and first hospitalization due to cardiovascular events.
| days | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Median Time to First Hospitalization Due to Cardiovascular Events | NA (NA to NA) | NA (NA to NA) |
The duration of hospitalization was the total number of days that a participant was hospitalized due to cardiovascular events. Participants with no hospitalization were excluded from analysis.
| days | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Duration of Hospitalization for Cardiovascular Events | 33.0 ± 42.0 | 28.2 ± 33.7 |
LVMI is determined by echocardiogram. LVMI indexed to body surface area (gram/square meter) estimated by LV cavity dimension and wall thickness at end-diastole. The change was calculated as week value minus baseline value.
| gram/square meter | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| LVMI, Baseline; n = 219, 232 | 120.32 ± 35.03 | 117.97 ± 34.34 |
| LVMI, Week 12; n = 171, 186 | -5.06 ± 24.81 | -2.87 ± 25.16 |
| LVMI, Week 24; n = 136, 146 | -6.58 ± 26.94 | -7.59 ± 25.59 |
| LVMI, Week 36; n = 74, 81 | -1.30 ± 36.04 | -7.53 ± 34.37 |
| LVMI, Week 48; n = 2, 11 | 2.00 ± 2.83 | -27.27 ± 29.47 |
LVEF is a marker of left ventricular systolic function and determined by echocardiogram. It is expressed as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage. FS is used as an estimate of myocardial contractility and determined by echocardiogram and measures as a percentage. The change for LVEF and FS was calculated as Week value minus baseline value.
| percentage | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| LVEF, Baseline; n = 219, 233 | 81.31 ± 7.24 | 81.95 ± 7.75 |
| LVEF, Week 12; n = 170, 186 | -0.08 ± 7.32 | 0.08 ± 7.34 |
| LVEF, Week 24; n = 135, 147 | -0.47 ± 6.82 | -0.23 ± 7.01 |
| LVEF, Week 36; n = 74, 81 | -0.61 ± 8.61 | 0.24 ± 6.75 |
| LVEF, Week 48; n = 2,11 | -0.46 ± 2.92 | 2.80 ± 8.12 |
| FS, Baseline; n = 219, 232 | 43.67 ± 7.12 | 44.67 ± 7.86 |
| FS, Week 12; n = 196, 212 | 0.13 ± 6.79 | 0.08 ± 7.34 |
| FS, Week 24; n = 174, 192 | 0.11 ± 7.10 | -0.19 ± 7.40 |
| FS, Week 36; n = 98, 105 | 0.05 ± 8.16 | 0.70 ± 7.80 |
| FS, Week 48; n = 4,12 | 1.00 ± 2.83 | 3.00 ± 8.58 |
Left Ventricular Volume is the estimated of left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) determined by Echocardiogram. The change was calculated as week value minus baseline value.
| milliliters per meter square | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| LV Volume, Baseline; n = 218, 232 | 67.73 ± 19.20 | 65.11 ± 19.24 |
| LV Volume, Week 12; n = 170, 186 | -2.83 ± 15.90 | 3.15 ± 15.46 |
| LV Volume, Week 24; n = 134, 146 | -0.69 ± 16.44 | 2.62 ± 18.56 |
| LV Volume, Week 36; n = 72, 80 | 3.34 ± 24.29 | 4.05 ± 19.08 |
| LV Volume, Week 48; n = 2, 11 | 14.48 ± 11.52 | 7.91 ± 23.37 |
Mean values of Echocardiography (ECHO) Parameters: Left Ventricular End Diastolic Diameter (LVEDD), Left Ventricular Posterior Wall Thickness (LVPWT), IV Septal Wall Thickness (IVSWT), LV End Systolic Diameter (LVESD), LV Relative wall thickness (LVRWT) at Baseline, Year 1, Year 2, Year 3 and Year 4 were presented.
| centimeters | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| LVEDD, Baseline, n = 219, 233 | 5.05 ± 0.67 | 4.91 ± 0.68 |
| LVEDD, Year 1, n = 170, 186 | 4.93 ± 0.62 | 4.94 ± 0.65 |
| LVEDD, Year 2, n = 135, 147 | 4.95 ± 0.63 | 4.93 ± 0.72 |
| LVEDD, Year 3, n = 74, 81 | 5.09 ± 0.71 | 4.88 ± 0.59 |
| LVEDD, Year 4, n = 2,11 | 5.21 ± 0.30 | 5.08 ± 0.79 |
| LVPWT, Baseline, n = 219, 233 | 1.05 ± 0.17 | 1.05 ± 0.17 |
| LVPWT, Year 1, n = 170, 186 | 1.02 ± 0.17 | 1.01 ± 0.16 |
| LVPWT, Year 2, n= 135, 147 | 1.01 ± 0.13 | 0.99 ± 0.14 |
| LVPWT, Year 3, n = 74, 81 | 1.01 ± 0.17 | 1.00 ± 0.13 |
| LVPWT, Year 4, n = 2,11 | 1.08 ± 0.13 | 0.92 ± 0.16 |
| IVSWT, Baseline, n = 219, 233 | 1.18 ± 0.24 | 1.20 ± 0.28 |
| IVSWT, Year 1, n = 170, 186 | 1.17 ± 0.23 | 1.13 ± 0.24 |
| IVSWT, Year 2, n = 135, 147 | 1.12 ± 0.21 | 1.11 ± 0.20 |
| IVSWT, Year 3, n = 74, 81 | 1.14 ± 0.25 | 1.12 ± 0.22 |
| IVSWT, Year 4, n = 2, 11 | 1.30 ± 0.05 | 1.04 ± 0.20 |
| LVESD, Baseline, n = 219, 233 | 2.85 ± 0.58 | 2.74 ± 0.66 |
| LVESD, Year 1, n = 170, 186 | 2.76 ± 0.56 | 2.73 ± 0.62 |
| LVESD, Year 2, n = 135, 147 | 2.78 ± 0.58 | 2.75 ± 0.68 |
| LVESD, Year 3, n = 74, 81 | 2.88 ± 0.75 | 2.67 ± 0.59 |
| LVESD, Year 4, n = 2, 11 | 2.93 ± 0.22 | 2.84 ± 0.57 |
| LVRWT, Baseline, n = 219, 233 | 0.42 ± 0.08 | 0.43 ± 0.09 |
| LVRWT, Year 1, n = 170, 186 | 0.42 ± 0.08 | 0.41 ± 0.08 |
| LVRWT, Year 2, n = 135, 147 | 0.41 ± 0.06 | 0.41 ± 0.07 |
| LVRWT, Year 3, n = 74, 81 | 0.41 ± 0.09 | 0.42 ± 0.07 |
| LVRWT, Year 4, n = 2, 11 | 0.41 ± 0.03 | 0.37 ± 0.07 |
The body surface area (BSA) was determined by Echocardiogram. Absolute mean values of Echocardiography (ECHO) Parameter: Body surface area (BSA) at Baseline, Year 1, Year 2, Year 3 and Year 4 were calculated and presented.
| Square meter | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| BSA, Baseline, n = 287, 290 | 1.83 ± 0.22 | 1.79 ± 0.20 |
| BSA, Year 1, n = 257, 261 | 1.83 ± 0.22 | 1.77 ± 0.23 |
| BSA, Year 2, n = 224, 234 | 1.82 ± 0.21 | 1.77 ± 0.19 |
| BSA, Year 3, n = 116, 121 | 1.82 ± 0.21 | 1.72 ± 0.19 |
| BSA, Year 4, n = 4, 11 | 1.96 ± 0.21 | 1.76 ± 0.22 |
The Quality of life was assessed on the basis of a change from baseline in the scores of each of the eight health scales in the SF-36 questionnaire. The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well-being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health (GH), vitality, mental health. The score for a section is an average of the individual question scores, which are scaled from 0 (worst level of functioning) to 100 (100=best level of functioning). The least squares mean (LSM) change from baseline was determined by Analysis of covariance (ANCOVA) model and presented for each of the eight health scale.
| units on a scale | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| General Health, Year 1 | 4.1 ± 1.01 | -0.1 ± 0.99 |
| General Health, Year 2 | 2.3 ± 1.14 | -1.9 ± 1.08 |
| Mental Health, Year 1 | 2.7 ± 0.98 | -2.1 ± 0.96 |
| Mental Health, Year 2 | 2.0 ± 1.07 | -0.4 ± 1.02 |
| Physical Function, Year 1 | 3.5 ± 1.1 | -2.1 ± 1.1 |
| Physical Function, Year 2 | -2.5 ± 1.33 | -2.5 ± 1.27 |
| Physical Role, Year 1 | 2.6 ± 2.23 | -5.5 ± 2.20 |
| Physical Role, Year 2 | -2.3 ± 2.59 | -7.3 ± 2.47 |
| Social Function, Year 1 | 1.8 ± 1.23 | -3.0 ± 1.21 |
| Social Function, Year 2 | -0.1 ± 1.44 | -3.0 ± 1.37 |
| Vitality Function, Year 1 | 3.9 ± 0.97 | -0.6 ± 0.95 |
| Vitality Function, Year 2 | 2.8 ± 1.10 | -1.0 ± 1.05 |
| Bodily Pain, Year 1 | -0.2 ± 1.37 | -2.1 ± 1.35 |
| Bodily Pain, Year 2 | -2.0 ± 1.53 | -1.2 ± 1.46 |
| Emotional Role, Year 1 | 0.4 ± 2.17 | -4.3 ± 2.14 |
| Emotional Role, Year 2 | -0.1 ± 2.51 | -2.2 ± 2.42 |
Anti-hypertensive is defined as class of drugs that are used to treat hypertension. Numbers (No.) of participants treated with at least one hypertensive medication/Treatment (Tt) according to class of drugs were reported.
| participants | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| No. of participants with at least one Tt | 287 | 282 |
| Calcium Channel Blocking Agents | 201 | 204 |
| Loop Diuretics | 183 | 180 |
| Angiotensin-Converting Enzyme Inhibitors | 158 | 153 |
| Beta-Adrenoceptor Blocking Agents | 169 | 136 |
| Angiotensin-II Receptor Antagonists | 89 | 96 |
| Alpha-Adrenoreceptor Antagonists | 87 | 73 |
| Antihypertensive Agents | 55 | 52 |
| Thiazide And Related Diuretics | 44 | 40 |
| Antianginal Agents | 6 | 5 |
| Potassium Sparing Diuretics | 4 | 7 |
| Aldosterone Antagonists | 2 | 5 |
| Cardiac Glycosides | 1 | 1 |
| Diuretics | 2 | 0 |
| Supplements | 1 | 1 |
| Calcium Compounds And Regulators | 0 | 1 |
| Miscellaneous Drugs | 0 | 1 |
| Tricyclic Antidepressants | 1 | 0 |
Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Values above and below the given reference range were determined as High or Low range values of the laboratory parameter. Roche's standard reference ranges for laboratory test parameters were used for the analysis. The laboratory parameters with marked abnormality are platelets (reference range is 150-350 10\^9 cells/liter \[L\]), creatinine (reference range is 0-133 micromole per liter), albumin (reference range is 35.0-55 g/L), phosphate (reference range is 0.84-1.45 millimole per liter \[mmol /L\]) and potassium (reference range is 3.4-4.8 mmol /L).
| participants | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Platelets - High; n = 206, 208 | 5 | 0 |
| Platelets - Low; n = 206, 208 | 13 | 15 |
| Creatinine - High; n = 206, 208 | 140 | 128 |
| Albumin - Low; n = 201, 205 | 6 | 9 |
| Phosphate - High; n = 206, 208 | 164 | 150 |
| Phosphate - Low; n = 206, 208 | 22 | 23 |
| Potassium - High; n = 206, 208 | 47 | 46 |
| Potassium - Low; n = 206, 208 | 4 | 6 |
Collected over Up to 4 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Early Epoetin Beta Therapy | — | 158/300 (52.7%) | 243/300 (81%) |
| Late Epoetin Beta Therapy | — | 145/302 (48%) | 228/302 (75.5%) |
| Event | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Cardiac Failure AcuteCardiac disorders | 11/300 | 19/302 |
| Renal FailureRenal and urinary disorders | 17/300 | 12/302 |
| ArrhythmiaCardiac disorders | 16/300 | 14/302 |
| Myocardial InfarctionCardiac disorders | 13/300 | 14/302 |
| Peripheral Vascular DisorderVascular disorders | 12/300 | 7/302 |
| Angina PectorisCardiac disorders | 11/300 | 4/302 |
| PneumoniaInfections and infestations | 9/300 | 9/302 |
| Renal ImpairmentRenal and urinary disorders | 5/300 | 9/302 |
| Urinary Tract InfectionInfections and infestations | 4/300 | 8/302 |
| Renal Failure ChronicRenal and urinary disorders | 7/300 | 6/302 |
| Event | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy |
|---|---|---|
| Renal FailureRenal and urinary disorders | 93/300 | 87/302 |
| HypertensionVascular disorders | 89/300 | 58/302 |
| Renal Failure ChronicRenal and urinary disorders | 33/300 | 46/302 |
| Back painMusculoskeletal and connective tissue disorders | 22/300 | 33/302 |
| HeadacheNervous system disorders | 30/300 | 15/302 |
| HyperkalaemiaMetabolism and nutrition disorders | 28/300 | 30/302 |
| Urinary tract infectionInfections and infestations | 26/300 | 29/302 |
| Upper respiratory tract infectionInfections and infestations | 16/300 | 28/302 |
| Renal ImpairmentRenal and urinary disorders | 27/300 | 23/302 |
| HyperphosphataemiaMetabolism and nutrition disorders | 27/300 | 22/302 |
Baseline characteristics were described for the intent-to-treat (ITT) population, which included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.
| Age, Continuous(years) | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy | Total |
|---|---|---|---|
| Mean | 59.3 ± 14.57 | 58.8 ± 13.73 | 59.0 ± 14.14 |
| Sex: Female, Male(Participants) | Early Epoetin Beta Therapy | Late Epoetin Beta Therapy | Total |
|---|---|---|---|
| Female | 130 | 148 | 278 |
| Male | 171 | 154 | 325 |
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Hoffmann-La Roche