Anemia
Conditions
Brief summary
This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]
iv 0.6 micrograms/kg every 2 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female patients, \>=18 years of age; * chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL); * no prior erythropoietin stimulating agent (ESA) therapy.
Exclusion criteria
* blood transfusion within the previous 4 weeks; * poorly controlled hypertension; * significant acute or chronic bleeding; * active malignant disease; * congestive heart failure (NYHA Class IV).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period | Baseline (Week 0) and Week 16 | The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16 | Week 12 to Week 16 | The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented. |
| Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16 | Week 12 to Week 16 | The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented. |
| Mean Platelet Count Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Number of Participants With Adverse Events, Serious Adverse Events and Deaths | Up to Week 18 | An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above |
| Number of Participants With Abnormal Electrocardiogram | Up to Week 16 | Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented. |
| Number of Participants With Reports of Blood Transfusions | Up to Week 16 | Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons. |
| Number of Participants With Reports of Anti-Epoetin Antibodies | Up to Week 16 | Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA. |
| Mean White Blood Cell Count Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Value of Mean Corpuscular Volume Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell. |
| Mean Hypochromic Red Blood Cells Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Serum Iron Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Serum Ferritin Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Transferrin Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter | Up to Week 16 | Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks. |
| Mean Transferrin Saturation Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented. |
| Mean Serum Albumin Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Serum Globulin Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Serum Creatinine Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Blood Urea Nitrogen Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Serum Potassium Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Serum Sodium Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Serum Phosphate Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Serum Bilirubin Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Aspartate Transaminase Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Alanine Aminotransferase Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Serum Alkaline Phosphatase Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
| Mean Total Iron-binding Capacity Over Time | Baseline (Week 0), Week 4, Week 10, and Week 16 | Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. |
Countries
India
Participant flow
Recruitment details
The study was conducted from 08 July 2008 to 31 May 2009 across 16 centers in India. A total of 189 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| MIRCERA Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. | 189 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Blood transfusion | 6 |
| Overall Study | Death | 8 |
| Overall Study | Failure to return | 4 |
| Overall Study | Other | 5 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | MIRCERA |
|---|---|
| Age, Continuous | 49.74 years STANDARD_DEVIATION 14.01 |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 189 |
| serious Total, serious adverse events | 24 / 189 |
Outcome results
Primary
Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period
The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.
Time frame: Baseline (Week 0) and Week 16
Population: The intent-to-treat (ITT) population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIRCERA | Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period | 2.11 gram/deciliter (g/dL) | Standard Deviation 1.3 |
p-value: <0.0001t-test, 2 sided
Secondary
Mean Alanine Aminotransferase Over Time
Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Alanine Aminotransferase Over Time | Week 10, n = 166 | 28.11 U/L | Standard Deviation 25.02 |
| MIRCERA | Mean Alanine Aminotransferase Over Time | Week 0, n = 185 | 27.89 U/L | Standard Deviation 19.38 |
| MIRCERA | Mean Alanine Aminotransferase Over Time | Week 4, n = 171 | 26.80 U/L | Standard Deviation 21.57 |
| MIRCERA | Mean Alanine Aminotransferase Over Time | Week 16, n = 157 | 29.21 U/L | Standard Deviation 24.45 |
Secondary
Mean Aspartate Transaminase Over Time
Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Aspartate Transaminase Over Time | Week 0, n = 184 | 22.33 Units/Liter (U/L) | Standard Deviation 13.06 |
| MIRCERA | Mean Aspartate Transaminase Over Time | Week 4, n = 171 | 21.69 Units/Liter (U/L) | Standard Deviation 14.93 |
| MIRCERA | Mean Aspartate Transaminase Over Time | Week 10, n = 166 | 24.61 Units/Liter (U/L) | Standard Deviation 19.44 |
| MIRCERA | Mean Aspartate Transaminase Over Time | Week 16, n = 157 | 22.63 Units/Liter (U/L) | Standard Deviation 18.53 |
Secondary
Mean Blood Urea Nitrogen Over Time
Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Blood Urea Nitrogen Over Time | Week 0, n = 181 | 68.98 mg/dL | Standard Deviation 48.61 |
| MIRCERA | Mean Blood Urea Nitrogen Over Time | Week 4, n = 170 | 66.19 mg/dL | Standard Deviation 42.13 |
| MIRCERA | Mean Blood Urea Nitrogen Over Time | Week 10, n = 168 | 67.21 mg/dL | Standard Deviation 42.29 |
| MIRCERA | Mean Blood Urea Nitrogen Over Time | Week 16, n = 157 | 69.88 mg/dL | Standard Deviation 47.77 |
Secondary
Mean Hypochromic Red Blood Cells Over Time
Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Hypochromic Red Blood Cells Over Time | Week 0, n = 39 | 3.84 cells per cubic millimeter | Standard Deviation 5.78 |
| MIRCERA | Mean Hypochromic Red Blood Cells Over Time | Week 4, n = 39 | 2.74 cells per cubic millimeter | Standard Deviation 1.13 |
| MIRCERA | Mean Hypochromic Red Blood Cells Over Time | Week 10, n = 36 | 3.23 cells per cubic millimeter | Standard Deviation 1.27 |
| MIRCERA | Mean Hypochromic Red Blood Cells Over Time | Week 16, n = 31 | 3.52 cells per cubic millimeter | Standard Deviation 1.5 |
Secondary
Mean Platelet Count Over Time
Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Platelet Count Over Time | Week 0, n = 186 | 214629.03 cells per cubic millimeter | Standard Deviation 77442.9 |
| MIRCERA | Mean Platelet Count Over Time | Week 4, n = 177 | 203050.85 cells per cubic millimeter | Standard Deviation 81720.79 |
| MIRCERA | Mean Platelet Count Over Time | Week 10, n = 167 | 204922.16 cells per cubic millimeter | Standard Deviation 78064.46 |
| MIRCERA | Mean Platelet Count Over Time | Week 16, n = 158 | 194550.63 cells per cubic millimeter | Standard Deviation 78937.74 |
Secondary
Mean Serum Albumin Over Time
Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Serum Albumin Over Time | Week 0, n = 185 | 3.51 g/dL | Standard Deviation 0.54 |
| MIRCERA | Mean Serum Albumin Over Time | Week 4, n = 172 | 3.48 g/dL | Standard Deviation 0.53 |
| MIRCERA | Mean Serum Albumin Over Time | Week 10, n = 167 | 3.57 g/dL | Standard Deviation 0.57 |
| MIRCERA | Mean Serum Albumin Over Time | Week 16, n = 155 | 3.61 g/dL | Standard Deviation 0.54 |
Secondary
Mean Serum Alkaline Phosphatase Over Time
Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Serum Alkaline Phosphatase Over Time | Week 0, n = 175 | 176.2 U/L | Standard Deviation 208.4 |
| MIRCERA | Mean Serum Alkaline Phosphatase Over Time | Week 4, n = 159 | 161.7 U/L | Standard Deviation 197.8 |
| MIRCERA | Mean Serum Alkaline Phosphatase Over Time | Week 10, n = 156 | 161.7 U/L | Standard Deviation 172.7 |
| MIRCERA | Mean Serum Alkaline Phosphatase Over Time | Week 16, n = 145 | 153.5 U/L | Standard Deviation 135.2 |
Secondary
Mean Serum Bilirubin Over Time
Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Serum Bilirubin Over Time | Week 0, n = 142 | 0.58 mg/dL | Standard Deviation 0.32 |
| MIRCERA | Mean Serum Bilirubin Over Time | Week 4, n = 124 | 0.68 mg/dL | Standard Deviation 0.86 |
| MIRCERA | Mean Serum Bilirubin Over Time | Week 10, n = 123 | 0.70 mg/dL | Standard Deviation 1.08 |
| MIRCERA | Mean Serum Bilirubin Over Time | Week 16, n = 117 | 0.62 mg/dL | Standard Deviation 0.5 |
Secondary
Mean Serum Creatinine Over Time
Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Serum Creatinine Over Time | Week 0, n = 186 | 8.25 mg/dL | Standard Deviation 3.05 |
| MIRCERA | Mean Serum Creatinine Over Time | Week 4, n = 171 | 8.65 mg/dL | Standard Deviation 3.09 |
| MIRCERA | Mean Serum Creatinine Over Time | Week 10, n = 168 | 9.48 mg/dL | Standard Deviation 7.69 |
| MIRCERA | Mean Serum Creatinine Over Time | Week 16, n = 158 | 9.05 mg/dL | Standard Deviation 3.31 |
Secondary
Mean Serum Ferritin Over Time
Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Serum Ferritin Over Time | Week 0, n = 188 | 963.28 nanogram /milliliter (ng/mL) | Standard Deviation 2398.89 |
| MIRCERA | Mean Serum Ferritin Over Time | Week 4, n = 170 | 702.37 nanogram /milliliter (ng/mL) | Standard Deviation 679.5 |
| MIRCERA | Mean Serum Ferritin Over Time | Week 10, n = 161 | 686.42 nanogram /milliliter (ng/mL) | Standard Deviation 723.22 |
| MIRCERA | Mean Serum Ferritin Over Time | Week 16, n = 153 | 641.26 nanogram /milliliter (ng/mL) | Standard Deviation 627.66 |
Secondary
Mean Serum Globulin Over Time
Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Serum Globulin Over Time | Week 0, n = 179 | 3.36 g/dL | Standard Deviation 0.67 |
| MIRCERA | Mean Serum Globulin Over Time | Week 4, n = 163 | 3.24 g/dL | Standard Deviation 0.63 |
| MIRCERA | Mean Serum Globulin Over Time | Week 10, n = 159 | 3.33 g/dL | Standard Deviation 0.63 |
| MIRCERA | Mean Serum Globulin Over Time | Week 16, n = 150 | 3.50 g/dL | Standard Deviation 2.5 |
Secondary
Mean Serum Iron Over Time
Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Serum Iron Over Time | Week 0, n = 187 | 91.72 microgram/deciliter (mcg/dL) | Standard Deviation 53.44 |
| MIRCERA | Mean Serum Iron Over Time | Week 4, n = 171 | 80.17 microgram/deciliter (mcg/dL) | Standard Deviation 39.45 |
| MIRCERA | Mean Serum Iron Over Time | Week 10, n = 166 | 87.62 microgram/deciliter (mcg/dL) | Standard Deviation 42.9 |
| MIRCERA | Mean Serum Iron Over Time | Week 16, n = 157 | 91.70 microgram/deciliter (mcg/dL) | Standard Deviation 47.36 |
Secondary
Mean Serum Phosphate Over Time
Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Serum Phosphate Over Time | Week 0, n = 166 | 6.20 mg/dL | Standard Deviation 7.5 |
| MIRCERA | Mean Serum Phosphate Over Time | Week 4, n = 156 | 6.32 mg/dL | Standard Deviation 7.58 |
| MIRCERA | Mean Serum Phosphate Over Time | Week 10, n = 155 | 8.71 mg/dL | Standard Deviation 34.13 |
| MIRCERA | Mean Serum Phosphate Over Time | Week 16, n = 146 | 6.17 mg/dL | Standard Deviation 2.16 |
Secondary
Mean Serum Potassium Over Time
Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Serum Potassium Over Time | Week 0, n = 183 | 5.76 millimoles per liter (mmol/L) | Standard Deviation 9.28 |
| MIRCERA | Mean Serum Potassium Over Time | Week 4, n = 168 | 5.23 millimoles per liter (mmol/L) | Standard Deviation 0.97 |
| MIRCERA | Mean Serum Potassium Over Time | Week 10, n = 168 | 7.53 millimoles per liter (mmol/L) | Standard Deviation 16.82 |
| MIRCERA | Mean Serum Potassium Over Time | Week 16, n = 157 | 8.30 millimoles per liter (mmol/L) | Standard Deviation 37.9 |
Secondary
Mean Serum Sodium Over Time
Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Serum Sodium Over Time | Week 0, n = 184 | 136.4 mmol/L | Standard Deviation 10.67 |
| MIRCERA | Mean Serum Sodium Over Time | Week 4, n = 168 | 136.3 mmol/L | Standard Deviation 11.32 |
| MIRCERA | Mean Serum Sodium Over Time | Week 10, n = 168 | 133.9 mmol/L | Standard Deviation 20.98 |
| MIRCERA | Mean Serum Sodium Over Time | Week 16, n = 156 | 137.0 mmol/L | Standard Deviation 11.19 |
Secondary
Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter
Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.
Time frame: Up to Week 16
Population: The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIRCERA | Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter | 6.10 Weeks | Standard Deviation 3.87 |
Secondary
Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented.
Time frame: Week 12 to Week 16
Population: The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIRCERA | Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16 | 3.07 Weeks | Standard Deviation 1 |
Secondary
Mean Total Iron-binding Capacity Over Time
Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Total Iron-binding Capacity Over Time | Week 0, n = 185 | 247.06 mcg/dL | Standard Deviation 64.08 |
| MIRCERA | Mean Total Iron-binding Capacity Over Time | Week 4, n = 166 | 243.25 mcg/dL | Standard Deviation 71.2 |
| MIRCERA | Mean Total Iron-binding Capacity Over Time | Week 10, n = 160 | 245.30 mcg/dL | Standard Deviation 69.25 |
| MIRCERA | Mean Total Iron-binding Capacity Over Time | Week 16, n = 153 | 245.30 mcg/dL | Standard Deviation 70.03 |
Secondary
Mean Transferrin Over Time
Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Transferrin Over Time | Week 0, n = 73 | 173.48 milligram per deciliter (mg/dL) | Standard Deviation 108.93 |
| MIRCERA | Mean Transferrin Over Time | Week 4, n = 66 | 176.97 milligram per deciliter (mg/dL) | Standard Deviation 105.16 |
| MIRCERA | Mean Transferrin Over Time | Week 10, n = 55 | 237.98 milligram per deciliter (mg/dL) | Standard Deviation 304.97 |
| MIRCERA | Mean Transferrin Over Time | Week 16, n = 58 | 181.50 milligram per deciliter (mg/dL) | Standard Deviation 174.83 |
Secondary
Mean Transferrin Saturation Over Time
Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Transferrin Saturation Over Time | Week 0, n = 186 | 40.39 Percentage of transferrin saturation | Standard Deviation 27.87 |
| MIRCERA | Mean Transferrin Saturation Over Time | Week 4, n=168 | 35.31 Percentage of transferrin saturation | Standard Deviation 22.46 |
| MIRCERA | Mean Transferrin Saturation Over Time | Week 10, n=161 | 36.91 Percentage of transferrin saturation | Standard Deviation 18.85 |
| MIRCERA | Mean Transferrin Saturation Over Time | Week 16, n = 153 | 38.31 Percentage of transferrin saturation | Standard Deviation 21.27 |
Secondary
Mean Value of Mean Corpuscular Volume Over Time
Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean Value of Mean Corpuscular Volume Over Time | Week 0, n = 183 | 87.05 Femtoliter | Standard Deviation 11.37 |
| MIRCERA | Mean Value of Mean Corpuscular Volume Over Time | Week 4, n = 169 | 89.17 Femtoliter | Standard Deviation 6.99 |
| MIRCERA | Mean Value of Mean Corpuscular Volume Over Time | Week 10, n = 167 | 88.46 Femtoliter | Standard Deviation 6.85 |
| MIRCERA | Mean Value of Mean Corpuscular Volume Over Time | Week 16, n = 159 | 88.03 Femtoliter | Standard Deviation 9.36 |
Secondary
Mean White Blood Cell Count Over Time
The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Mean White Blood Cell Count Over Time | Week 0, n = 187 | 9382.89 cells per cubic millimeter | Standard Deviation 11644.69 |
| MIRCERA | Mean White Blood Cell Count Over Time | Week 4, n = 173 | 9181.27 cells per cubic millimeter | Standard Deviation 12689.96 |
| MIRCERA | Mean White Blood Cell Count Over Time | Week 10, n = 167 | 9361.38 cells per cubic millimeter | Standard Deviation 13319.73 |
| MIRCERA | Mean White Blood Cell Count Over Time | Week 16, n = 159 | 9023.71 cells per cubic millimeter | Standard Deviation 13109.61 |
Secondary
Number of Participants With Abnormal Electrocardiogram
Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.
Time frame: Up to Week 16
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Number of Participants With Abnormal Electrocardiogram | Participants with abnormal ECG, Week 0, n=189 | 52 Participants |
| MIRCERA | Number of Participants With Abnormal Electrocardiogram | Participants with abnormal ECG, Week 16, n=164 | 49 Participants |
Secondary
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above
Time frame: Up to Week 18
Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Number of Participants With Adverse Events, Serious Adverse Events and Deaths | Participants with any AE | 53 Participants |
| MIRCERA | Number of Participants With Adverse Events, Serious Adverse Events and Deaths | Participants with SAE | 24 Participants |
| MIRCERA | Number of Participants With Adverse Events, Serious Adverse Events and Deaths | Deaths | 8 Participants |
Secondary
Number of Participants With Reports of Anti-Epoetin Antibodies
Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.
Time frame: Up to Week 16
Population: The ITT population included all participants who receive at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MIRCERA | Number of Participants With Reports of Anti-Epoetin Antibodies | 0 Participants |
Secondary
Number of Participants With Reports of Blood Transfusions
Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.
Time frame: Up to Week 16
Population: The ITT population included all participants who receive at least one dose of study drug. Participants available at the time of assessment were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Number of Participants With Reports of Blood Transfusions | White blood cells transfusions | 1 Participants |
| MIRCERA | Number of Participants With Reports of Blood Transfusions | Pack cell transfusions | 6 Participants |
| MIRCERA | Number of Participants With Reports of Blood Transfusions | Pure red cell transfusions | 0 Participants |
Secondary
Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.
Time frame: Week 12 to Week 16
Population: The ITT population included all participants who received at least one dose of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MIRCERA | Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16 | 46.20 percentage of participants |