Trial Outcomes & Findings for A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) (NCT NCT01379963)
NCT ID: NCT01379963
Last Updated: 2017-07-13
Results Overview
Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.
COMPLETED
780 participants
Up to 6 months
2017-07-13
Participant Flow
Participant milestones
| Measure |
Methoxy-Polyethylene-Glycol-Epoetin Beta
Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
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|---|---|
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Overall Study
STARTED
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780
|
|
Overall Study
COMPLETED
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780
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta)
Baseline characteristics by cohort
| Measure |
Methoxy-Polyethylene-Glycol-Epoetin Beta
n=780 Participants
Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
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|---|---|
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Age, Continuous
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68.64 Years
STANDARD_DEVIATION 14.10 • n=5 Participants
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Sex/Gender, Customized
Female
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442 Participants
n=5 Participants
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Sex/Gender, Customized
Male
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325 Participants
n=5 Participants
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Sex/Gender, Customized
Missing
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13 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.
Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.
Outcome measures
| Measure |
Methoxy-Polyethylene-Glycol-Epoetin Beta
n=774 Participants
Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
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|---|---|
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Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)
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17.18 Percentage of participants
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SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.
Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.
Outcome measures
| Measure |
Methoxy-Polyethylene-Glycol-Epoetin Beta
n=776 Participants
Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
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|---|---|
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Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL
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3.09 Percentage of participants
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Adverse Events
Methoxy-Polyethylene-Glycol-Epoetin Beta
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigators is free to publish in reputed journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER