Anemia
Conditions
Brief summary
This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Interventions
DRUGDarbepoetin alfa
Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52.
DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]
RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively).
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients \>=18 years of age; * chronic renal anemia; * on dialysis therapy for at least 12 weeks before screening; * receiving darbepoetin alfa iv for at least 8 weeks before screening.
Exclusion criteria
* women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of another investigational drug within 4 weeks before screening, or during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period | Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36) | A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline (Week -4 to Week -1) and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. The analysis used the last observation carried forward (LOCF) for missing Hb values for correction of the impact of early drop outs. The baseline period was defined as Week -4 to Week -1. The evaluation period was defined as Week 29 to Week 36. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods | Week 1 to Week 36 | A combined data of the number of participants who received Red Blood Cell (RBC) transfusions during the titration and evaluation periods is reported. A period of 28 weeks after the first dose of the study drug was used for dose titration and stabilization of Hb concentration. The dose titration period was followed by an 8-week evaluation period (weeks 29 to 36). |
| Number of Participants With Marked Laboratory Abnormalities | Up to Week 52 | A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10\^9/liter \[L\]), platelets (100 - 550 10\^9/L), (alanine aminotransferase \[(ALAT)\] (0 - 110 units per liter \[U/L\]), alkaline phosphatase (ALP) (0 - 220 U/L), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin \>= 30 g/L, phosphate (0.75 - 1.60 millimole per liter \[mmol/L\]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L). |
| Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration | Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36) | The average Hb of all values recorded during the evaluation period was calculated, and this average was subtracted from the average baseline Hb values for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline Hb concentration is displayed. The evaluation period was defined as Week 29 to Week 36. |
| Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52 | Baseline, Week 36, and Week 52 | Change in pulse rate (beats per minute \[bpm\]) from baseline values includes only those participants with both a baseline (BL) value and a value for specified time period. |
| Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths | Up to Week 52 | An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported. |
| Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Baseline, Week 36, and Week 52 | Blood pressure Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) was measured by manual assessment or automated reading throughout the study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic and diastolic blood pressures were recorded before dialysis (BD) and after dialysis (AD). |
Countries
Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Spain, Sweden, Switzerland
Participant flow
Recruitment details
A total of 313 participants were randomized in this study conducted from 10 March 2004 to 31 August 2005 in 12 countries.
Participants by arm
| Arm | Count |
|---|---|
| RO0503821 (1x/2 Weeks) Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively). | 153 |
| Darbepoetin (1x/1-2 Weeks) Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52. | 156 |
| Total | 309 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Death | 12 | 10 |
| Overall Study | Dialysis | 0 | 1 |
| Overall Study | Dialysis Discontinued | 1 | 0 |
| Overall Study | Enrolled in Nocturnal Hemodialysis Study | 0 | 1 |
| Overall Study | Investigators Discretion | 1 | 0 |
| Overall Study | Kidney Transplantation | 9 | 5 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Participant's decision | 1 | 0 |
| Overall Study | Participants Vacation | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Started Nocturnal Dialysis | 0 | 1 |
| Overall Study | Stop Dialysis | 0 | 1 |
| Overall Study | Transplantation | 5 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | RO0503821 (1x/2 Weeks) | Darbepoetin (1x/1-2 Weeks) | Total |
|---|---|---|---|
| Age, Continuous | 62.5 Years STANDARD_DEVIATION 15.72 | 61.9 Years STANDARD_DEVIATION 14.74 | 62.2 Years STANDARD_DEVIATION 15.21 |
| Sex: Female, Male Female | 56 Participants | 74 Participants | 130 Participants |
| Sex: Female, Male Male | 97 Participants | 82 Participants | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 97 / 153 | 93 / 156 |
| serious Total, serious adverse events | 71 / 153 | 75 / 156 |
Outcome results
Primary
Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period
A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline (Week -4 to Week -1) and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. The analysis used the last observation carried forward (LOCF) for missing Hb values for correction of the impact of early drop outs. The baseline period was defined as Week -4 to Week -1. The evaluation period was defined as Week 29 to Week 36.
Time frame: Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)
Population: The per protocol population was all randomized and treated participants, except those who had not met criteria for stable baseline Hb,and adequate iron levels or had hemoglobinopathies/hemolysis, RBC transfusion/blood loss, \<5 recorded Hb values during evaluation or missed administrations of trial drugs in week 26 to 35.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period | 0.05 gram per deciliter (g/dL) | Standard Deviation 0.96 |
| Darbepoetin (1x/1-2 Weeks) | Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period | -0.10 gram per deciliter (g/dL) | Standard Deviation 0.92 |
Comparison: RO0503821 group was compared to darbepoetin alfa group, using analysis of covariance (ANCOVA) with the independent variable as treatment group and Hb at baseline and geographical region as covariates. The test for non-inferiority was based on the lower limit of 2-sided 95% confidence interval (CI) for difference in adjusted mean between 2 groups. If this lower limit was \> or = to -0.75 g/dL, the RO0503821 group was regarded as clinically non-inferior to darbepoetin alfa group, with 90% power.p-value: <0.000195% CI: [-0.049, 0.408]ANCOVA, CI for difference between groups
Secondary
Mean Change in Blood Pressure From Baseline at Week 36 and Week 52
Blood pressure Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) was measured by manual assessment or automated reading throughout the study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic and diastolic blood pressures were recorded before dialysis (BD) and after dialysis (AD).
Time frame: Baseline, Week 36, and Week 52
Population: The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time point were included in the analysis (n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in SBP, BD, at Week 36, n = 130, 134 | -2 millimeters of mercury (mm Hg) | Standard Deviation 23 |
| RO0503821 (1x/2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in DBP, BD, at Week 36, n = 130, 134 | -0 millimeters of mercury (mm Hg) | Standard Deviation 12.8 |
| RO0503821 (1x/2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in SBP, BD, at Week 52, n = 117, 130 | 2 millimeters of mercury (mm Hg) | Standard Deviation 24.6 |
| RO0503821 (1x/2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in DBP, BD, at Week 52, n = 117,130 | 0 millimeters of mercury (mm Hg) | Standard Deviation 12.4 |
| RO0503821 (1x/2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in SBP, AD, at Week 36, n = 130, 132 | -3 millimeters of mercury (mm Hg) | Standard Deviation 25.9 |
| RO0503821 (1x/2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in DBP, AD, at Week 36, n = 130, 132 | -3 millimeters of mercury (mm Hg) | Standard Deviation 13.6 |
| RO0503821 (1x/2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in SBP, AD, at Week 52, n = 116,129 | -0 millimeters of mercury (mm Hg) | Standard Deviation 26.9 |
| RO0503821 (1x/2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in DBP, AD, at Week 52, n = 116,129 | -1 millimeters of mercury (mm Hg) | Standard Deviation 15 |
| Darbepoetin (1x/1-2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in DBP, AD, at Week 52, n = 116,129 | -4 millimeters of mercury (mm Hg) | Standard Deviation 14.9 |
| Darbepoetin (1x/1-2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in SBP, BD, at Week 36, n = 130, 134 | -2 millimeters of mercury (mm Hg) | Standard Deviation 24.3 |
| Darbepoetin (1x/1-2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in SBP, AD, at Week 36, n = 130, 132 | -3 millimeters of mercury (mm Hg) | Standard Deviation 24 |
| Darbepoetin (1x/1-2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in DBP, BD, at Week 36, n = 130, 134 | -2 millimeters of mercury (mm Hg) | Standard Deviation 16.4 |
| Darbepoetin (1x/1-2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in SBP, AD, at Week 52, n = 116,129 | -3 millimeters of mercury (mm Hg) | Standard Deviation 25 |
| Darbepoetin (1x/1-2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in SBP, BD, at Week 52, n = 117, 130 | -4 millimeters of mercury (mm Hg) | Standard Deviation 22 |
| Darbepoetin (1x/1-2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in DBP, AD, at Week 36, n = 130, 132 | -4 millimeters of mercury (mm Hg) | Standard Deviation 14.2 |
| Darbepoetin (1x/1-2 Weeks) | Mean Change in Blood Pressure From Baseline at Week 36 and Week 52 | Change in DBP, BD, at Week 52, n = 117,130 | -3 millimeters of mercury (mm Hg) | Standard Deviation 16 |
Secondary
Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52
Change in pulse rate (beats per minute \[bpm\]) from baseline values includes only those participants with both a baseline (BL) value and a value for specified time period.
Time frame: Baseline, Week 36, and Week 52
Population: The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time point were included in the analysis (n).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52 | Change From Baseline to Week 36, n=126, 128 | -1 beats per minute | Standard Deviation 11.9 |
| RO0503821 (1x/2 Weeks) | Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52 | Change From Baseline to Week 52, n=112, 126 | -1 beats per minute | Standard Deviation 13 |
| Darbepoetin (1x/1-2 Weeks) | Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52 | Change From Baseline to Week 36, n=126, 128 | 1 beats per minute | Standard Deviation 10.6 |
| Darbepoetin (1x/1-2 Weeks) | Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52 | Change From Baseline to Week 52, n=112, 126 | 0 beats per minute | Standard Deviation 13.5 |
Secondary
Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration
The average Hb of all values recorded during the evaluation period was calculated, and this average was subtracted from the average baseline Hb values for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline Hb concentration is displayed. The evaluation period was defined as Week 29 to Week 36.
Time frame: Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)
Population: The Intent-to-Treat (ITT) population was defined as all randomized participants. Participants with available data at the time of evaluation were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RO0503821 (1x/2 Weeks) | Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration | 91 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration | 102 Participants |
Secondary
Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.
Time frame: Up to Week 52
Population: The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths | Number of participants with any AEs | 135 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths | Number of participants with any SAEs | 71 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths | Number of deaths (all causes) | 13 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths | Number of participants with any AEs | 143 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths | Number of participants with any SAEs | 75 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths | Number of deaths (all causes) | 12 Participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities
A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10\^9/liter \[L\]), platelets (100 - 550 10\^9/L), (alanine aminotransferase \[(ALAT)\] (0 - 110 units per liter \[U/L\]), alkaline phosphatase (ALP) (0 - 220 U/L), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin \>= 30 g/L, phosphate (0.75 - 1.60 millimole per liter \[mmol/L\]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L).
Time frame: Up to Week 52
Population: The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time points were included in the analysis (n).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | WBC, High; n=152,153 | 4 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Albumin, Low; n=143,142 | 12 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | ALAT, high; n=152,154 | 4 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Phosphate, High; n=152,154 | 60 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Platelets, Low; n=152,153 | 6 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Phosphate, Low; n=152,154 | 9 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | ALP, High; n=152,154 | 6 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Potassium, High; n=152,154 | 38 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | WBC, Low; n=152,153 | 6 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Potassium, Low; n=152,154 | 0 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | ASAT, High; n=148,151 | 7 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Glucose (fasting), High; n=103,100 | 1 Participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Platelets, High; n=152,153 | 0 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Glucose (fasting), High; n=103,100 | 0 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Platelets, High; n=152,153 | 6 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Platelets, Low; n=152,153 | 4 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | WBC, High; n=152,153 | 3 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | WBC, Low; n=152,153 | 4 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | ALAT, high; n=152,154 | 2 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | ALP, High; n=152,154 | 11 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | ASAT, High; n=148,151 | 5 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Albumin, Low; n=143,142 | 14 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Phosphate, High; n=152,154 | 61 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Phosphate, Low; n=152,154 | 13 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Potassium, High; n=152,154 | 31 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Potassium, Low; n=152,154 | 1 Participants |
Secondary
Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods
A combined data of the number of participants who received Red Blood Cell (RBC) transfusions during the titration and evaluation periods is reported. A period of 28 weeks after the first dose of the study drug was used for dose titration and stabilization of Hb concentration. The dose titration period was followed by an 8-week evaluation period (weeks 29 to 36).
Time frame: Week 1 to Week 36
Population: The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RO0503821 (1x/2 Weeks) | Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods | 19 Participants |
| Darbepoetin (1x/1-2 Weeks) | Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods | 16 Participants |