Anemia
Conditions
Brief summary
This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. Data from each patient will be collected over 12 months of Mircera therapy.
Interventions
DRUGmethoxy polyethylene glycol-ep [Mircera]
As prescribed by physician
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>/= 18 years of age * chronic kidney disease * informed consent for data transmission
Exclusion criteria
* serious hematological or infectious disease * acute bleeding in the 16 weeks preceding data collection * participation in an interventional trial * female patients: pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Satisfied With Treatment at Final Visit | Month 12 or early discontinuation | Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were very satisfied, satisfied, undecided, or not satisfied. Data for this outcome measure was reported for overall participants. |
| Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Month 0 to Month 12 | Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (\<) 10 g/dL or greater than (\>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented. |
| Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Month 0 to Month 12 | The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (\<65 years, greater than or equal to \[\>=\] 65 years) and center size (\>100 participants, less than or equal to \[\<=\] 100 participants) is presented. |
| Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Month 6 to Month 12 | The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (\<65 years, \>=65 years) and center size (\>100 participants, \<=100 participants) is presented. |
| Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size | Month 0 to Month 12 | For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (\<65 years, \>=65 years), and center size (\>100 participants, \<=100 participants) is presented. Data for this outcome measure was reported for overall participants. |
| Serum Ferritin Values | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants. |
| Serum Iron Values | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants. |
| Transferrin Values | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants. |
| Transferrin Saturation Values | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants. |
| C-reactive Protein (CRP) Values | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants. |
| Number of Physicians Satisfied With Treatment at Final Visit | Month 12 or early discontinuation | Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were very satisfied, satisfied, undecided, or not satisfied. One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants. |
| Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion | Month 12 or early discontinuation | At final visit, physicians were asked to answer (yes or no) the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants. |
| Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Month 12 or early discontinuation | At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants. |
| Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy | Month 12 or early discontinuation | Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants. |
Countries
Germany
Participant flow
Pre-assignment details
Data of this non-interventional study were analyzed by the following strata: predialysis participants versus hemodialysis participants, unless otherwise specified.
Participants by arm
| Arm | Count |
|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary. | 326 |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary. | 1,184 |
| Total | 1,510 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 129 |
| Overall Study | Dialysis dependency | 22 |
| Overall Study | Discontinuation of treatment | 103 |
| Overall Study | Hospitalization | 28 |
| Overall Study | Lost to Follow-up | 31 |
| Overall Study | Missing | 37 |
| Overall Study | Other | 148 |
| Overall Study | Transplantation | 28 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Total |
|---|---|---|---|
| Age, Continuous | 71.8 years STANDARD_DEVIATION 13.3 | 68.0 years STANDARD_DEVIATION 13.8 | 68.8 years STANDARD_DEVIATION 13.8 |
| Sex: Female, Male Female | 158 Participants | 479 Participants | 637 Participants |
| Sex: Female, Male Male | 168 Participants | 705 Participants | 873 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 346 | 196 / 1,201 |
| serious Total, serious adverse events | 7 / 346 | 67 / 1,201 |
Outcome results
Primary
C-reactive Protein (CRP) Values
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants.
Time frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with C-reactive protein values at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 0 (n=916) | 13.3 mg/dL | Standard Deviation 28.5 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 1 (n=641) | 15.0 mg/dL | Standard Deviation 30.7 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 2 (n=529) | 12.9 mg/dL | Standard Deviation 24.1 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 3 (n=589) | 21.6 mg/dL | Standard Deviation 119.2 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 4 (n=677) | 14.5 mg/dL | Standard Deviation 74.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 5 (n=552) | 12.1 mg/dL | Standard Deviation 20.6 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 6 (n=567) | 15.0 mg/dL | Standard Deviation 35.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 7 (n=623) | 11.4 mg/dL | Standard Deviation 19 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 8 (n=471) | 16.5 mg/dL | Standard Deviation 66 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 9 (n=514) | 12.4 mg/dL | Standard Deviation 22 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 10 (n=535) | 11.1 mg/dL | Standard Deviation 18.2 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 11 (n=478) | 13.0 mg/dL | Standard Deviation 29.6 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | C-reactive Protein (CRP) Values | Month 12 (n=488) | 11.2 mg/dL | Standard Deviation 23.4 |
Primary
Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (\<65 years, \>=65 years), and center size (\>100 participants, \<=100 participants) is presented. Data for this outcome measure was reported for overall participants.
Time frame: Month 0 to Month 12
Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size | Predialysis (n=317) | 1.3 g/dL | Standard Deviation 0.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size | Hemodialysis (n=1172) | 1.6 g/dL | Standard Deviation 0.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size | Age <65 years (n=467) | 1.6 g/dL | Standard Deviation 0.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size | Age >=65 years (n=1022) | 1.5 g/dL | Standard Deviation 0.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size | Center size >100 participants (n=654) | 1.5 g/dL | Standard Deviation 0.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size | Center size <=100 participants (n=835) | 1.6 g/dL | Standard Deviation 0.8 |
Primary
Number of Participants Satisfied With Treatment at Final Visit
Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were very satisfied, satisfied, undecided, or not satisfied. Data for this outcome measure was reported for overall participants.
Time frame: Month 12 or early discontinuation
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Satisfied With Treatment at Final Visit | Very satisfied | 593 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Satisfied With Treatment at Final Visit | Satisfied | 713 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Satisfied With Treatment at Final Visit | Undecided | 114 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Satisfied With Treatment at Final Visit | Not satisfied | 16 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Satisfied With Treatment at Final Visit | Missing | 74 participants |
Primary
Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion
At final visit, physicians were asked to answer (yes or no) the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants.
Time frame: Month 12 or early discontinuation
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion | Yes | 944 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion | No | 490 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion | Missing | 76 participants |
Primary
Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants.
Time frame: Month 12 or early discontinuation
Population: FAS. N (number of participants analyzed) = participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy | Aranesp | 30 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy | Biopoin | 1 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy | Biosimilar | 21 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy | Erypo | 50 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy | NeoRecormon | 46 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy | Missing | 21 participants |
Primary
Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants.
Time frame: Month 12 or early discontinuation
Population: FAS. N (number of participants analyzed) = participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Missing | 10 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Death | 116 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Participant's decision | 24 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Physician's decision | 177 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Insufficient efficacy | 1 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Adverse event | 5 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Methoxy polyethylene glycol-epoetin not available | 57 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Organizational reasons | 34 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Hospitalization/change of medical center | 19 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Transplantation | 18 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Treatment interruption/ESA currently not necessary | 14 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | High hemoglobin levels | 10 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Relocation/vacation of participant | 6 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Lost to follow-up | 6 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Dialysis | 5 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Unknown | 5 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Change of therapy | 4 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Participant does not want to continue dialysis | 1 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Therapy withdrawal | 1 participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | Therapy omission | 1 participants |
Primary
Number of Physicians Satisfied With Treatment at Final Visit
Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were very satisfied, satisfied, undecided, or not satisfied. One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants.
Time frame: Month 12 or early discontinuation
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Physicians Satisfied With Treatment at Final Visit | Very satisfied | 685 physicians |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Physicians Satisfied With Treatment at Final Visit | Satisfied | 602 physicians |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Physicians Satisfied With Treatment at Final Visit | Undecided | 136 physicians |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Physicians Satisfied With Treatment at Final Visit | Not satisfied | 31 physicians |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Number of Physicians Satisfied With Treatment at Final Visit | Missing | 56 physicians |
Primary
Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range
Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (\<) 10 g/dL or greater than (\>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.
Time frame: Month 0 to Month 12
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Hemoglobin value <10 g/dL | 97.9 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Hemoglobin value >13 g/dL | 33.7 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Hemoglobin value <10 g/dL | 72.9 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Hemoglobin value >13 g/dL | 35.3 percentage of participants |
Primary
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (\<65 years, greater than or equal to \[\>=\] 65 years) and center size (\>100 participants, less than or equal to \[\<=\] 100 participants) is presented.
Time frame: Month 0 to Month 12
Population: FAS. n = participants evaluable for specified category for each arm group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | No dose modifications: Hb 10-12 g/dL (n=157, 242) | 11.5 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | No dose modifications: Hb 11-12 g/dL (n=157, 242) | 0.6 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | No dose modifications: Hb 11-13 g/dL (n=157, 242) | 11.5 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | With dose modifications: Hb 10-12g/dL (n=169, 942) | 6.5 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | With dose modifications: Hb 11-12g/dL (n=169, 942) | 0.6 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | With dose modifications: Hb 11-13g/dL (n=169, 942) | 8.9 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Age <65 years: Hb 10-12 g/dL (n=70, 402) | 10.0 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Age <65 years: Hb 11-12 g/dL (n=70, 402) | 1.4 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Age <65 years: Hb 11-13 g/dL (n=70, 402) | 8.6 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Age >=65 years: Hb 10-12 g/dL (n=256, 782) | 8.6 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Age >=65 years: Hb 11-12 g/dL (n=256, 782) | 0.4 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Age >=65 years: Hb 11-13 g/dL (n=256, 782) | 10.5 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Center size >100: Hb 10-12 g/dL (n=99, 563) | 17.2 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Center size >100: Hb 11-12 g/dL (n=99, 563) | 2.0 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Center size >100: Hb 11-13 g/dL (n=99, 563) | 13.1 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Center size <=100: Hb 10-12 g/dL (n=227, 621) | 5.3 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Center size <=100: Hb 11-12 g/dL (n=227, 621) | 0 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Center size <=100: Hb 11-13 g/dL (n=227, 621) | 8.8 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Center size >100: Hb 11-12 g/dL (n=99, 563) | 0.4 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | No dose modifications: Hb 10-12 g/dL (n=157, 242) | 8.7 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Age >=65 years: Hb 10-12 g/dL (n=256, 782) | 5.1 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | No dose modifications: Hb 11-12 g/dL (n=157, 242) | 0.8 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Center size <=100: Hb 11-13 g/dL (n=227, 621) | 5.5 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | No dose modifications: Hb 11-13 g/dL (n=157, 242) | 11.2 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Age >=65 years: Hb 11-12 g/dL (n=256, 782) | 0.1 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | With dose modifications: Hb 10-12g/dL (n=169, 942) | 4.9 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Center size >100: Hb 11-13 g/dL (n=99, 563) | 7.5 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | With dose modifications: Hb 11-12g/dL (n=169, 942) | 0.1 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Age >=65 years: Hb 11-13 g/dL (n=256, 782) | 5.4 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | With dose modifications: Hb 11-13g/dL (n=169, 942) | 5.2 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Center size <=100: Hb 11-12 g/dL (n=227, 621) | 0.2 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Age <65 years: Hb 10-12 g/dL (n=70, 402) | 6.7 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Center size >100: Hb 10-12 g/dL (n=99, 563) | 6.0 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Age <65 years: Hb 11-12 g/dL (n=70, 402) | 0.5 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Center size <=100: Hb 10-12 g/dL (n=227, 621) | 5.3 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Age <65 years: Hb 11-13 g/dL (n=70, 402) | 8.8 percentage of participants |
Primary
Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (\<65 years, \>=65 years) and center size (\>100 participants, \<=100 participants) is presented.
Time frame: Month 6 to Month 12
Population: FAS. n = participants evaluable for specified category for each arm group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Age >=65 years: Hb 10-12 g/dL (n=256, 782) | 9.8 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | No dose modifications: Hb 10-12 g/dL (n=157, 242) | 9.6 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Age >=65 years: Hb 11-12 g/dL (n=256, 782) | 1.6 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | With dose modifications: Hb 11-13g/dL (n=169, 942) | 9.5 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Age >=65 years: Hb 11-13 g/dL (n=256, 782) | 7.8 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | No dose modifications: Hb 11-13 g/dL (n=157, 242) | 8.3 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Center size >100: Hb 10-12 g/dL (n=99, 563) | 20.2 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Age <65 years: Hb 10-12 g/dL (n=70, 402) | 11.4 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Center size >100: Hb 11-12 g/dL (n=99, 563) | 7.1 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | With dose modifications: Hb 10-12g/dL (n=169, 942) | 10.7 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Center size >100: Hb 11-13 g/dL (n=99, 563) | 15.2 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Age <65 years: Hb 11-12 g/dL (n=70, 402) | 4.3 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Center size <=100: Hb 10-12 g/dL (n=227, 621) | 5.7 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | No dose modifications: Hb 11-12 g/dL (n=157, 242) | 3.2 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Center size <=100: Hb 11-12 g/dL (n=227, 621) | 0 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Age <65 years: Hb 11-13 g/dL (n=70, 402) | 12.9 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Center size <=100: Hb 11-13 g/dL (n=227, 621) | 6.2 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | With dose modifications: Hb 11-12g/dL (n=169, 942) | 1.2 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Center size <=100: Hb 11-13 g/dL (n=227, 621) | 14.2 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | No dose modifications: Hb 10-12 g/dL (n=157, 242) | 12.8 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | No dose modifications: Hb 11-12 g/dL (n=157, 242) | 2.5 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | With dose modifications: Hb 10-12g/dL (n=169, 942) | 14.6 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | With dose modifications: Hb 11-12g/dL (n=169, 942) | 2.3 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | With dose modifications: Hb 11-13g/dL (n=169, 942) | 15.1 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Age <65 years: Hb 10-12 g/dL (n=70, 402) | 14.7 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Age <65 years: Hb 11-12 g/dL (n=70, 402) | 3.0 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Age <65 years: Hb 11-13 g/dL (n=70, 402) | 18.4 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Age >=65 years: Hb 10-12 g/dL (n=256, 782) | 14.1 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Age >=65 years: Hb 11-12 g/dL (n=256, 782) | 2.0 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Age >=65 years: Hb 11-13 g/dL (n=256, 782) | 12.7 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Center size >100: Hb 10-12 g/dL (n=99, 563) | 14.9 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Center size >100: Hb 11-12 g/dL (n=99, 563) | 3.4 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Center size >100: Hb 11-13 g/dL (n=99, 563) | 15.1 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Center size <=100: Hb 10-12 g/dL (n=227, 621) | 13.7 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | Center size <=100: Hb 11-12 g/dL (n=227, 621) | 1.4 percentage of participants |
| Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | No dose modifications: Hb 11-13 g/dL (n=157, 242) | 12.8 percentage of participants |
Primary
Serum Ferritin Values
Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.
Time frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum ferritin values at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 8 (n=333) | 488.4 ng/mL | Standard Deviation 414.5 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 9 (n=323) | 493.0 ng/mL | Standard Deviation 414.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 10 (n=388) | 554.8 ng/mL | Standard Deviation 431 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 11 (n=307) | 542.3 ng/mL | Standard Deviation 416.2 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 12 (n=335) | 478.6 ng/mL | Standard Deviation 354 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 0 (n=807) | 402.5 ng/mL | Standard Deviation 365.3 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 1 (n=509) | 526.5 ng/mL | Standard Deviation 453.1 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 2 (n=420) | 479.9 ng/mL | Standard Deviation 451.5 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 3 (n=399) | 412.6 ng/mL | Standard Deviation 349.3 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 4 (n=439) | 517.4 ng/mL | Standard Deviation 423 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 5 (n=366) | 518.2 ng/mL | Standard Deviation 424.5 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 6 (n=411) | 462.0 ng/mL | Standard Deviation 403.9 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Ferritin Values | Month 7 (n=443) | 567.1 ng/mL | Standard Deviation 514.5 |
Primary
Serum Iron Values
Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.
Time frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum iron values at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 9 (n=284) | 74.3 mcg/dL | Standard Deviation 50.1 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 0 (n=644) | 73.3 mcg/dL | Standard Deviation 65.9 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 1 (n=339) | 69.5 mcg/dL | Standard Deviation 33.4 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 2 (n=351) | 68.8 mcg/dL | Standard Deviation 37.1 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 3 (n=375) | 74.5 mcg/dL | Standard Deviation 74.4 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 4 (n=362) | 67.7 mcg/dL | Standard Deviation 31.2 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 5 (n=323) | 68.9 mcg/dL | Standard Deviation 31 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 6 (n=347) | 72.1 mcg/dL | Standard Deviation 32.7 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 7 (n=362) | 74.4 mcg/dL | Standard Deviation 34.2 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 8 (n=294) | 67.0 mcg/dL | Standard Deviation 31.9 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 10 (n=341) | 69.0 mcg/dL | Standard Deviation 29.2 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 11 (n=263) | 64.8 mcg/dL | Standard Deviation 28.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Serum Iron Values | Month 12 (n=263) | 70.2 mcg/dL | Standard Deviation 29.7 |
Primary
Transferrin Saturation Values
Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants.
Time frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with transferrin saturation values at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 0 (n=489) | 24.4 percent transferrin saturation | Standard Deviation 11.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 1 (n=298) | 27.3 percent transferrin saturation | Standard Deviation 15.2 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 2 (n=308) | 26.7 percent transferrin saturation | Standard Deviation 13.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 3 (n=282) | 28.0 percent transferrin saturation | Standard Deviation 13.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 4 (n=321) | 26.4 percent transferrin saturation | Standard Deviation 12.9 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 5 (n=276) | 27.5 percent transferrin saturation | Standard Deviation 14.1 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 6 (n=320) | 27.2 percent transferrin saturation | Standard Deviation 13.6 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 7 (n=316) | 28.2 percent transferrin saturation | Standard Deviation 13.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 8 (n=254) | 26.8 percent transferrin saturation | Standard Deviation 14 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 9 (n=241) | 27.4 percent transferrin saturation | Standard Deviation 12.3 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 10 (n=294) | 27.3 percent transferrin saturation | Standard Deviation 12.5 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 11 (n=227) | 25.7 percent transferrin saturation | Standard Deviation 12.1 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Saturation Values | Month 12 (n=220) | 27.0 percent transferrin saturation | Standard Deviation 11.8 |
Primary
Transferrin Values
Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.
Time frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with tansferrin values at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 0 (n=544) | 196.1 mg/dL | Standard Deviation 46.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 1 (n=266) | 187.9 mg/dL | Standard Deviation 40.4 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 2 (n=271) | 192.5 mg/dL | Standard Deviation 43.1 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 3 (n=274) | 192.6 mg/dL | Standard Deviation 44.2 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 4 (n=292) | 187.7 mg/dL | Standard Deviation 43.6 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 5 (n=231) | 193.6 mg/dL | Standard Deviation 41.9 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 6 (n=282) | 193.9 mg/dL | Standard Deviation 47 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 7 (n=287) | 188.4 mg/dL | Standard Deviation 44 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 8 (n=199) | 192.0 mg/dL | Standard Deviation 43.2 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 9 (n=205) | 188.1 mg/dL | Standard Deviation 44.7 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 10 (n=251) | 182.3 mg/dL | Standard Deviation 39.5 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 11 (n=175) | 186.9 mg/dL | Standard Deviation 45.1 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Transferrin Values | Month 12 (n=179) | 189.9 mg/dL | Standard Deviation 46.1 |
Secondary
Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants.
Time frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Population: FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 0 (n=1485) | 109.1 mcg | Standard Deviation 75.9 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 1 (n=1336) | 121.8 mcg | Standard Deviation 102.2 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 2 (n=1292) | 124.6 mcg | Standard Deviation 96.7 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 3 (n=1234) | 126.2 mcg | Standard Deviation 94.1 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 4 (n=1192) | 129.4 mcg | Standard Deviation 99.8 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 5 (n=1157) | 130.5 mcg | Standard Deviation 110.2 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 6 (n=1115) | 128.3 mcg | Standard Deviation 101.7 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 7 (n=1075) | 129.3 mcg | Standard Deviation 105.1 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 8 (n=1014) | 125.7 mcg | Standard Deviation 101.9 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 9 (n=993) | 122.9 mcg | Standard Deviation 98.2 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 10 (n=954) | 124.3 mcg | Standard Deviation 101.7 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 11 (n=917) | 124.5 mcg | Standard Deviation 106.3 |
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Month 12 (n=907) | 121.1 mcg | Standard Deviation 99.1 |