Anemia
Conditions
Brief summary
This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Interventions
iv 3 times weekly, as prescribed
DRUGmethoxy polyethylene glycol-epoetin beta (Mircera)
60, 100 or 180 micrograms sc (starting dose) every 2 weeks
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 sc epoetin 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 From Baseline to Evaluation Periods | 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 (AUC) approach, for both periods separately. Change in Hb concentration between the baseline 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. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Red Blood Cell Transfusions | Up to Week 36 | The number of participants who received RBC transfusions were reported. |
| Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths | Up to week 52 | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| 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/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 millimoles per liter \[mmol/L\]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L). |
| Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration | Evaluation period (Week 29 to Week 36) | All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36. |
| Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants | From Baseline (Week -4 to Week -1) to Week 36 and Week 52 | Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants. |
| Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | From Baseline (Week -4 to Week -1) to Week 36 and Week 52 | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants. |
| Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants | From Baseline (Week -4 to Week -1) to Week 36 and Week 52 | Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants. |
| Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | From Baseline (Week -4 to Week -1) to Week 36 and Week 52 | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants. |
Countries
Belgium, Brazil, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Mexico, New Zealand, Panama, Poland, Puerto Rico, South Africa, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States
Participant flow
Recruitment details
A total of 817 participants were enrolled in this study conducted from 03 March 2004 to 23 September 2005 at 92 centers worldwide.
Pre-assignment details
A total of 572 participants were randomized, of which 1 participant did not received the study drug.
Participants by arm
| Arm | Count |
|---|---|
| RO0503821 (1x/2 Weeks) Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the Epoetin dose of\<8000, 8000-16000,or \>16000 International units \[IU\]/Week, administered during the week preceding the switch to the study drug. | 190 |
| RO0503821 (1x/4 Weeks) Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the Epoetin dose of\<8000, 8000-16000, or \>16000 IU/Week administered during the week preceding the switch to the study drug. | 190 |
| Epoetin Reference Eligible participants received their ongoing weekly subcutaneous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks. | 191 |
| Total | 571 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 |
| Overall Study | Death | 12 | 18 | 11 |
| Overall Study | Failure to return | 1 | 0 | 0 |
| Overall Study | Insufficient therapeutic response | 2 | 0 | 0 |
| Overall Study | Other-Non safety reason | 18 | 15 | 19 |
| Overall Study | Withdrawal by Subject | 2 | 10 | 1 |
Baseline characteristics
| Characteristic | RO0503821 (1x/2 Weeks) | RO0503821 (1x/4 Weeks) | Epoetin Reference | Total |
|---|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 15.4 | 62.5 years STANDARD_DEVIATION 15.16 | 60.4 years STANDARD_DEVIATION 14.7 | 61.1 years STANDARD_DEVIATION 15.1 |
| Sex: Female, Male Female | 82 Participants | 73 Participants | 81 Participants | 236 Participants |
| Sex: Female, Male Male | 108 Participants | 117 Participants | 110 Participants | 335 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 113 / 190 | 131 / 190 | 111 / 191 |
| serious Total, serious adverse events | 70 / 190 | 73 / 190 | 85 / 191 |
Outcome results
Primary
Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods
A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline 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. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is 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 included all randomized participants except those not meeting inclusion criterion related to stable baseline Hb values, inadequate iron status, hemoglobinopathies/hemolysis, RBC transfusion/blood loss, with \<5 recorded Hb values during the evaluation period, with missing administrations of the study drug/ reference drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods | -0.00 g/dL | Standard Deviation 0.96 |
| RO0503821 (1x/4 Weeks) | Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods | -0.11 g/dL | Standard Deviation 0.97 |
| Epoetin Reference | Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods | -0.12 g/dL | Standard Deviation 1.04 |
Comparison: The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)p-value: <0.000197.5% CI: [-0.098, 0.38]ANCOVA, CI for difference between groups
Comparison: The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)p-value: <0.000197.5% CI: [-0.262, 0.217]ANCOVA, CI for difference between groups
Secondary
Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants
Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants.
Time frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Population: Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as 'n'.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants | Pulse rate (Week 36, n=147,149, 156 ) | -0 BpM | Standard Deviation 11.8 |
| RO0503821 (1x/2 Weeks) | Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants | Pulse rate (Week 52, n= 140, 135, 142) | -0 BpM | Standard Deviation 10.6 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants | Pulse rate (Week 36, n=147,149, 156 ) | 1 BpM | Standard Deviation 11.3 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants | Pulse rate (Week 52, n= 140, 135, 142) | 1 BpM | Standard Deviation 12.5 |
| Epoetin Reference | Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants | Pulse rate (Week 36, n=147,149, 156 ) | -0 BpM | Standard Deviation 12 |
| Epoetin Reference | Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants | Pulse rate (Week 52, n= 140, 135, 142) | -0 BpM | Standard Deviation 12.3 |
Secondary
Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants
Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants.
Time frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Population: Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as 'n'.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants | Pulse rate (Week 36, n=147,149, 156) | 1 BpM | Standard Deviation 16.7 |
| RO0503821 (1x/2 Weeks) | Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants | Pulse rate (Week 52, n= 140, 135, 142) | -3 BpM | Standard Deviation 12.7 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants | Pulse rate (Week 36, n=147,149, 156) | 4 BpM | Standard Deviation 12.2 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants | Pulse rate (Week 52, n= 140, 135, 142) | 1 BpM | Standard Deviation 7.8 |
| Epoetin Reference | Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants | Pulse rate (Week 36, n=147,149, 156) | 6 BpM | Standard Deviation 6.9 |
| Epoetin Reference | Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants | Pulse rate (Week 52, n= 140, 135, 142) | 2 BpM | Standard Deviation 7.8 |
Secondary
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants.
Time frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Population: Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as 'n'.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | DBP- before dialysis (Week 36, n=150,153, 157) | 0 mmHG | Standard Deviation 12.2 |
| RO0503821 (1x/2 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | DBP- before dialysis (Week 52, n= 143, 136, 144) | -1 mmHG | Standard Deviation 13.8 |
| RO0503821 (1x/2 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | DBP - After dialysis (Week 36, n=150, 150, 157) | 1 mmHG | Standard Deviation 13.2 |
| RO0503821 (1x/2 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | DBP - After dialysis (Week 52, n= 141, 136, 142) | 0 mmHG | Standard Deviation 15 |
| RO0503821 (1x/2 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | SBP - before dialysis(Week 36, n=150, 153, 158) | 1 mmHG | Standard Deviation 22.1 |
| RO0503821 (1x/2 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | SBP - before dialysis(Week 52, n=143, 136,144) | -1 mmHG | Standard Deviation 25.2 |
| RO0503821 (1x/2 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | SBP - After dialysis (Week 36, n=150, 152, 158) | -1 mmHG | Standard Deviation 24.4 |
| RO0503821 (1x/2 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | SBP - After dialysis (Week 52, n=141, 136, 142) | 1 mmHG | Standard Deviation 24.1 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | DBP - After dialysis (Week 36, n=150, 150, 157) | -0 mmHG | Standard Deviation 17.3 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | SBP - After dialysis (Week 36, n=150, 152, 158) | -0 mmHG | Standard Deviation 27.1 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | DBP - After dialysis (Week 52, n= 141, 136, 142) | 0 mmHG | Standard Deviation 14.9 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | SBP - before dialysis(Week 36, n=150, 153, 158) | 4 mmHG | Standard Deviation 26.1 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | SBP - before dialysis(Week 52, n=143, 136,144) | 3 mmHG | Standard Deviation 23.1 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | DBP- before dialysis (Week 36, n=150,153, 157) | 0 mmHG | Standard Deviation 15.5 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | DBP- before dialysis (Week 52, n= 143, 136, 144) | -1 mmHG | Standard Deviation 11.1 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | SBP - After dialysis (Week 52, n=141, 136, 142) | -2 mmHG | Standard Deviation 23.4 |
| Epoetin Reference | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | DBP - After dialysis (Week 36, n=150, 150, 157) | -1 mmHG | Standard Deviation 15.7 |
| Epoetin Reference | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | DBP- before dialysis (Week 52, n= 143, 136, 144) | 2 mmHG | Standard Deviation 14.3 |
| Epoetin Reference | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | DBP- before dialysis (Week 36, n=150,153, 157) | 1 mmHG | Standard Deviation 14.6 |
| Epoetin Reference | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | DBP - After dialysis (Week 52, n= 141, 136, 142) | 2 mmHG | Standard Deviation 15.6 |
| Epoetin Reference | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | SBP - After dialysis (Week 36, n=150, 152, 158) | -2 mmHG | Standard Deviation 26.8 |
| Epoetin Reference | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | SBP - before dialysis(Week 52, n=143, 136,144) | 1 mmHG | Standard Deviation 23.4 |
| Epoetin Reference | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | SBP - before dialysis(Week 36, n=150, 153, 158) | -1 mmHG | Standard Deviation 22.7 |
| Epoetin Reference | Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants | SBP - After dialysis (Week 52, n=141, 136, 142) | 2 mmHG | Standard Deviation 23.9 |
Secondary
Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants.
Time frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Population: Safety population included all participants who received at least one dose of study medication. Maximum number of participants available at the time of assessment were analysed and reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | DBP (Week 36, n=7,10,12 ) | 2 mm HG | Standard Deviation 12.8 |
| RO0503821 (1x/2 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | DBP (Week 52, n= 8, 9, 12) | 1 mm HG | Standard Deviation 10.3 |
| RO0503821 (1x/2 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | SBP - (Week 36, n=7, 10, 12) | 3 mm HG | Standard Deviation 26.7 |
| RO0503821 (1x/2 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | SBP - (Week 52, n=8, 9,12) | 4 mm HG | Standard Deviation 22.1 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | SBP - (Week 52, n=8, 9,12) | -20 mm HG | Standard Deviation 36.9 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | DBP (Week 36, n=7,10,12 ) | -7 mm HG | Standard Deviation 13.9 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | SBP - (Week 36, n=7, 10, 12) | -20 mm HG | Standard Deviation 33.5 |
| RO0503821 (1x/4 Weeks) | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | DBP (Week 52, n= 8, 9, 12) | -8 mm HG | Standard Deviation 18.7 |
| Epoetin Reference | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | SBP - (Week 52, n=8, 9,12) | 12 mm HG | Standard Deviation 19.6 |
| Epoetin Reference | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | DBP (Week 52, n= 8, 9, 12) | 2 mm HG | Standard Deviation 18.5 |
| Epoetin Reference | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | SBP - (Week 36, n=7, 10, 12) | 7 mm HG | Standard Deviation 29 |
| Epoetin Reference | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants | DBP (Week 36, n=7,10,12 ) | 2 mm HG | Standard Deviation 15.5 |
Secondary
Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration
All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36.
Time frame: Evaluation period (Week 29 to Week 36)
Population: The Intent-to-Treat (ITT) population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RO0503821 (1x/2 Weeks) | Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration | 124 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration | 111 participants |
| Epoetin Reference | Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration | 127 participants |
Secondary
Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Up to week 52
Population: Safety population included all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths | Any SAE's | 70 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths | Any AE's | 171 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths | Deaths | 13 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths | Any SAE's | 73 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths | Any AE's | 177 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths | Deaths | 18 participants |
| Epoetin Reference | Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths | Any AE's | 167 participants |
| Epoetin Reference | Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths | Deaths | 12 participants |
| Epoetin Reference | Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths | Any SAE's | 85 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/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 millimoles 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: Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment were denoted as 'n'.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | WBC, low; n=189,189, 188 | 3 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | RBC, high; n = 118, 112, 115 | 0 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Phosphate, low; n=189,189, 188 | 14 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Albumin, low; n=182,186, 185 | 16 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | ALAT, high; n=189,189, 188 | 6 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Potassium, low; n=189,189, 188 | 1 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | ASAT, high; n=185,189, 186 | 4 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | ALP, high; n=189,189, 188 | 5 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Platelets, low; n=189,189, 188 | 8 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Potassium, high; n=189,189, 188 | 32 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | RBC, low; n = 118, 112, 115 | 48 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Glucose fasting, low; n=126,137, 124 | 0 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Phosphate, high; n=189,189, 188 | 84 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | WBC, high; n=189,189, 188 | 1 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Glucose fasting, high; n=126,137, 124 | 1 participants |
| RO0503821 (1x/2 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Platelets, high; n=189,189, 188 | 0 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Albumin, low; n=182,186, 185 | 20 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Platelets, high; n=189,189, 188 | 1 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Platelets, low; n=189,189, 188 | 11 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | RBC, high; n = 118, 112, 115 | 2 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | RBC, low; n = 118, 112, 115 | 48 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | WBC, high; n=189,189, 188 | 2 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | WBC, low; n=189,189, 188 | 4 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | ALAT, high; n=189,189, 188 | 11 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | ALP, high; n=189,189, 188 | 8 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | ASAT, high; n=185,189, 186 | 5 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Phosphate, high; n=189,189, 188 | 78 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Phosphate, low; n=189,189, 188 | 17 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Potassium, high; n=189,189, 188 | 38 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Potassium, low; n=189,189, 188 | 4 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Glucose fasting, high; n=126,137, 124 | 2 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Marked Laboratory Abnormalities | Glucose fasting, low; n=126,137, 124 | 0 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | RBC, low; n = 118, 112, 115 | 73 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | Platelets, low; n=189,189, 188 | 1 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | Glucose fasting, low; n=126,137, 124 | 0 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | Phosphate, low; n=189,189, 188 | 18 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | RBC, high; n = 118, 112, 115 | 1 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | Glucose fasting, high; n=126,137, 124 | 2 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | Potassium, high; n=189,189, 188 | 38 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | Phosphate, high; n=189,189, 188 | 82 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | Platelets, high; n=189,189, 188 | 1 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | ALP, high; n=189,189, 188 | 11 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | ALAT, high; n=189,189, 188 | 6 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | Potassium, low; n=189,189, 188 | 1 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | ASAT, high; n=185,189, 186 | 2 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | WBC, low; n=189,189, 188 | 4 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | WBC, high; n=189,189, 188 | 5 participants |
| Epoetin Reference | Number of Participants With Marked Laboratory Abnormalities | Albumin, low; n=182,186, 185 | 17 participants |
Secondary
Number of Participants With Red Blood Cell Transfusions
The number of participants who received RBC transfusions were reported.
Time frame: Up to Week 36
Population: Safety population included all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RO0503821 (1x/2 Weeks) | Number of Participants With Red Blood Cell Transfusions | 12 participants |
| RO0503821 (1x/4 Weeks) | Number of Participants With Red Blood Cell Transfusions | 20 participants |
| Epoetin Reference | Number of Participants With Red Blood Cell Transfusions | 19 participants |