Skip to content

Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine

Non-interventional Study to Investigate the Long Term Effects of MIRCERA in Clinical Routine

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01309269
Enrollment
1083
Registered
2011-03-07
Start date
2010-09-30
Completion date
2014-04-30
Last updated
2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Brief summary

This observational study will assess the effect of long-term treatment with Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients with renal anemia. Data will be collected from each patient for at least 24 months.

Interventions

None listed

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

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 * Patients with chronic kidney disease (CKD), stages IV and V * Treatment with Mircera according to label

Exclusion criteria

* Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin Levels at Monthly IntervalsPrior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24Hemoglobin levels were measured as grams/deciliter (g/dL).
Percentage of Participants Within Pre-defined Range of Hemoglobin ValuesMonths 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL.
Average Methoxy Polyethylene Glycol-epoetin Beta DoseMonths 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.

Countries

Germany

Participant flow

Pre-assignment details

In this non-interventional study, physician was completely free in his/her decision which participants he/she treated with the medication selected in this study, what dosage was chosen, which diagnostic measures were taken, how the course of treatment was monitored and what accompanying or supplemental medications were prescribed.

Participants by arm

ArmCount
Methoxy Polyethylene Glycol-epoetin Beta
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
978
Total978

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdministrative Problems141
Overall StudyAdverse Event56
Overall StudyEnrolled but not Treated107
Overall StudyKidney Transplant25
Overall StudyLack of Acceptance15
Overall StudyOther256
Overall StudyOther Erythropoiesis-stimulating Agents119
Overall StudyStudy Completion Data Not Recorded95
Overall StudyWithdrawal by Subject25

Baseline characteristics

CharacteristicMethoxy Polyethylene Glycol-epoetin Beta
Age, Continuous67.0 years
STANDARD_DEVIATION 13.9
Gender
Female
428 Participants
Gender
Male
550 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
120 / 978
serious
Total, serious adverse events
172 / 978

Outcome results

Primary

Average Methoxy Polyethylene Glycol-epoetin Beta Dose

Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.

Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

Population: Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during study period considered.

ArmMeasureGroupValue (MEAN)Dispersion
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 24 (Day 706-735) (n=46)116.30 microgram (mcg)Standard Deviation 88
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 1 (Day 1-45) (n=933)103.23 microgram (mcg)Standard Deviation 68.23
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 2 (Day 46-75) (n=797)102.27 microgram (mcg)Standard Deviation 70.96
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 3 (Day 76-105) (n=785)102.48 microgram (mcg)Standard Deviation 71.23
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 4 (Day 106-135) (n=758)102.64 microgram (mcg)Standard Deviation 70.88
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 5 (Day 136-165) (n=700)104.55 microgram (mcg)Standard Deviation 74.81
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 6 (Day 166-195) (n=673)102.87 microgram (mcg)Standard Deviation 76.01
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 7 (Day 196-225) (n=631)101.08 microgram (mcg)Standard Deviation 77.76
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 8 (Day 226-255) (n=562)103.13 microgram (mcg)Standard Deviation 77.41
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 9 (Day 256-285) (n=509)103.31 microgram (mcg)Standard Deviation 78.43
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 10 (Day 286-315) (n=481)104.62 microgram (mcg)Standard Deviation 77.59
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 11 (Day 316-345) (n=452)103.37 microgram (mcg)Standard Deviation 75.16
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 12 (Day 346-375) (n=396)104.88 microgram (mcg)Standard Deviation 77.43
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 13 (Day 376-405) (n=382)103.63 microgram (mcg)Standard Deviation 79.82
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 14 (Day 406-435) (n=375)107.37 microgram (mcg)Standard Deviation 81.52
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 15 (Day 436-465) (n=328)105.49 microgram (mcg)Standard Deviation 80.5
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 16 (Day 466-495) (n=290)113.21 microgram (mcg)Standard Deviation 82.47
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 17 (Day 496-525) (n=281)107.10 microgram (mcg)Standard Deviation 82.63
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 18 (Day 526-555) (n=262)101.96 microgram (mcg)Standard Deviation 81.36
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 19 (Day 556-585) (n=230)107.25 microgram (mcg)Standard Deviation 80.88
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 20 (Day 586-615) (n=196)110.81 microgram (mcg)Standard Deviation 87.95
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 21 (Day 616-645) (n=201)107.80 microgram (mcg)Standard Deviation 90.14
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 22 (Day 646-675) (n=166)109.98 microgram (mcg)Standard Deviation 88.88
Methoxy Polyethylene Glycol-epoetin BetaAverage Methoxy Polyethylene Glycol-epoetin Beta DoseMonth 23 (Day 676-705) (n=144)118.49 microgram (mcg)Standard Deviation 102.6
Primary

Hemoglobin Levels at Monthly Intervals

Hemoglobin levels were measured as grams/deciliter (g/dL).

Time frame: Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

Population: Effectiveness Population I: all participants for whom at least 1 hemoglobin value was documented after the first application of methoxy polyethylene glycol-epoetin beta during the study course. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.

ArmMeasureGroupValue (MEAN)Dispersion
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsPrior to Day 1 (n=926)11.15 g/dLStandard Deviation 1.21
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 1 (Day 1-45) (n=802)11.31 g/dLStandard Deviation 1.24
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 2 (Day 46-75) (n=715)11.33 g/dLStandard Deviation 1.23
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 3 (Day 76-105) (n=684)11.28 g/dLStandard Deviation 1.32
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 4 (Day 106-135) (n=685)11.28 g/dLStandard Deviation 1.25
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 5 (Day 136-165) (n=602)11.25 g/dLStandard Deviation 1.22
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 6 (Day 166-195) (n=580)11.36 g/dLStandard Deviation 1.27
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 7 (Day 196-225) (n=541)11.30 g/dLStandard Deviation 1.26
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 8 (Day 226-255) (n=516)11.31 g/dLStandard Deviation 1.25
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 9 (Day 256-285) (n=436)11.46 g/dLStandard Deviation 1.28
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 10 (Day 286-315) (n=423)11.40 g/dLStandard Deviation 1.27
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 11 (Day 316-345) (n=402)11.44 g/dLStandard Deviation 1.31
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 12 (Day 346-375) (n=374)11.31 g/dLStandard Deviation 1.27
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 13 (Day 376-405) (n=351)11.29 g/dLStandard Deviation 1.16
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 14 (Day 406-435) (n=344)11.26 g/dLStandard Deviation 1.16
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 15 (Day 436-465) (n=304)11.30 g/dLStandard Deviation 1.2
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 16 (Day 466-495) (n=272)11.37 g/dLStandard Deviation 1.19
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 17 (Day 496-525) (n=265)11.34 g/dLStandard Deviation 1.27
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 18 (Day 526-555) (n=226)11.36 g/dLStandard Deviation 1.13
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 19 (Day 556-585) (n=213)11.28 g/dLStandard Deviation 1.22
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 20 (Day 586-615) (n=187)11.16 g/dLStandard Deviation 1.16
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 21 (Day 616-645) (n=186)11.23 g/dLStandard Deviation 1.16
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 22 (Day 646-675) (n=167)11.38 g/dLStandard Deviation 1.21
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 23 (Day 676-705) (n=143)11.34 g/dLStandard Deviation 1.13
Methoxy Polyethylene Glycol-epoetin BetaHemoglobin Levels at Monthly IntervalsMonth 24 (Day 706-735) (n=37)11.66 g/dLStandard Deviation 1.23
Primary

Percentage of Participants Within Pre-defined Range of Hemoglobin Values

Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL.

Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

Population: Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.

ArmMeasureGroupValue (NUMBER)
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 1 (Day 1-45) (n=802)37.5 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 1 (Day 1-45) (n=802)61.6 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 1 (Day 1-45) (n=802)56.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 1 (Day 1-45) (n=802)80.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 2 (Day 46-75) (n=715)39.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 2 (Day 46-75) (n=715)62.2 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 2 (Day 46-75) (n=715)58.2 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 2 (Day 46-75) (n=715)81.4 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 3 (Day 76-105) (n=684)33.5 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 3 (Day 76-105) (n=684)58.3 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 3 (Day 76-105) (n=684)53.1 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 3 (Day 76-105) (n=684)77.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 4 (Day 106-135) (n=685)35.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 4 (Day 106-135) (n=685)62.6 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 4 (Day 106-135) (n=685)53.4 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 4 (Day 106-135) (n=685)81.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 5 (Day 136-165) (n=602)36.2 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 5 (Day 136-165) (n=602)65.3 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 5 (Day 136-165) (n=602)53.5 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 5 (Day 136-165) (n=602)82.6 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 6 (Day 166-195) (n=580)41.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 6 (Day 166-195) (n=580)64.8 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 6 (Day 166-195) (n=580)57.1 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 6 (Day 166-195) (n=580)80.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 7 (Day 196-225) (n=541)39.4 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 7 (Day 196-225) (n=541)62.8 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 7 (Day 196-225) (n=541)56.6 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 7 (Day 196-225) (n=541)80.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 8 (Day 226-255) (n=516)37.8 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 8 (Day 226-255) (n=516)60.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 8 (Day 226-255) (n=516)56.4 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 8 (Day 226-255) (n=516)79.5 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 9 (Day 256-285) (n=436)38.1 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 9 (Day 256-285) (n=436)58.5 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 9 (Day 256-285) (n=436)58.5 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 9 (Day 256-285) (n=436)78.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 10 (Day 286-315) (n=423)39.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 10 (Day 286-315) (n=423)60.8 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 10 (Day 286-315) (n=423)59.1 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 10 (Day 286-315) (n=423)80.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 11 (Day 316-345) (n=402)38.3 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 11 (Day 316-345) (n=402)61.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 11 (Day 316-345) (n=402)57.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 11 (Day 316-345) (n=402)80.6 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 12 (Day 346-375) (n=374)36.6 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 12 (Day 346-375) (n=374)60.7 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 12 (Day 346-375) (n=374)54.8 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 12 (Day 346-375) (n=374)78.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 13 (Day 376-405) (n=351)37.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 13 (Day 376-405) (n=351)63.2 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 13 (Day 376-405) (n=351)57.5 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 13 (Day 376-405) (n=351)82.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 14 (Day 406-435) (n=344)35.8 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 14 (Day 406-435) (n=344)64.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 14 (Day 406-435) (n=344)54.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 14 (Day 406-435) (n=344)83.1 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 15 (Day 436-465) (n=304)36.2 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 15 (Day 436-465) (n=304)64.1 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 15 (Day 436-465) (n=304)54.3 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 15 (Day 436-465) (n=304)82.2 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 16 (Day 466-495) (n=272)34.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 16 (Day 466-495) (n=272)64.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 16 (Day 466-495) (n=272)54.8 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 16 (Day 466-495) (n=272)83.8 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 17 (Day 496-525) (n=265)35.8 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 17 (Day 496-525) (n=265)64.2 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 17 (Day 496-525) (n=265)52.1 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 17 (Day 496-525) (n=265)80.4 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 18 (Day 526-555) (n=226)41.6 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 18 (Day 526-555) (n=226)67.3 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 18 (Day 526-555) (n=226)57.5 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 18 (Day 526-555) (n=226)83.2 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 19 (Day 556-585) (n=213)37.1 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 19 (Day 556-585) (n=213)62.4 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 19 (Day 556-585) (n=213)54.5 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 19 (Day 556-585) (n=213)79.8 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 20 (Day 586-615) (n=187)36.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 20 (Day 586-615) (n=187)62.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 20 (Day 586-615) (n=187)54.0 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 20 (Day 586-615) (n=187)79.1 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 21 (Day 616-645) (n=186)37.1 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 21 (Day 616-645) (n=186)63.4 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 21 (Day 616-645) (n=186)55.4 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 21 (Day 616-645) (n=186)81.7 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 22 (Day 646-675) (n=167)47.9 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 22 (Day 646-675) (n=167)68.3 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 22 (Day 646-675) (n=167)63.5 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 22 (Day 646-675) (n=167)83.8 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 23 (Day 676-705) (n=143)30.8 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 23 (Day 676-705) (n=143)61.5 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 23 (Day 676-705) (n=143)54.5 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 23 (Day 676-705) (n=143)85.3 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-12 g/dL: Month 24 (Day 706-735) (n=37)35.1 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-12 g/dL: Month 24 (Day 706-735) (n=37)54.1 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values11-13 g/dL: Month 24 (Day 706-735) (n=37)51.4 percentage of participants
Methoxy Polyethylene Glycol-epoetin BetaPercentage of Participants Within Pre-defined Range of Hemoglobin Values10-13 g/dL: Month 24 (Day 706-735) (n=37)70.3 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026