Trial Outcomes & Findings for Observational Study of Methoxy Polyethylene Glycol Epoetin Beta Daily Use in Participants on Peritoneal Dialysis (NCT NCT02596945)
NCT ID: NCT02596945
Last Updated: 2017-07-02
Results Overview
Recruitment status
COMPLETED
Target enrollment
223 participants
Primary outcome timeframe
Month 7 to Month 9
Results posted on
2017-07-02
Participant Flow
Participant milestones
| Measure |
Peritoneal Dialysis Participants
Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC) were observed for a period of 9 months.
|
|---|---|
|
Overall Study
STARTED
|
223
|
|
Overall Study
Treated
|
220
|
|
Overall Study
COMPLETED
|
167
|
|
Overall Study
NOT COMPLETED
|
56
|
Reasons for withdrawal
| Measure |
Peritoneal Dialysis Participants
Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC) were observed for a period of 9 months.
|
|---|---|
|
Overall Study
No documentation of study drug dosing
|
3
|
|
Overall Study
Other
|
32
|
|
Overall Study
Change to hemodialysis
|
15
|
|
Overall Study
Other Erythropoietin stimulating agent
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Missing
|
1
|
Baseline Characteristics
Observational Study of Methoxy Polyethylene Glycol Epoetin Beta Daily Use in Participants on Peritoneal Dialysis
Baseline characteristics by cohort
| Measure |
Peritoneal Dialysis Participants
n=220 Participants
Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
|
|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 15.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Month 7 to Month 9Population: Modified Efficacy Set (MES) population (All participants who received at least 1 dose of study drug and for whom at least 2 hemoglobin measurements were available during the evaluation period (Month 7 to Month 9).
Outcome measures
| Measure |
Peritoneal Dialysis Participants
n=162 Participants
Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
|
|---|---|
|
Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)
|
14.8 percentage of participants
|
SECONDARY outcome
Timeframe: Month 7 to Month 9Population: MES population.
Outcome measures
| Measure |
Peritoneal Dialysis Participants
n=162 Participants
Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
|
|---|---|
|
Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)
|
38.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 9 monthsPopulation: MES population.
Outcome measures
| Measure |
Peritoneal Dialysis Participants
n=162 Participants
Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
|
|---|---|
|
Average Duration in Days Mircera Was Administered at a Stable Dose
|
182.1 days
Standard Deviation 122.7
|
Adverse Events
Peritoneal Dialysis Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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. Investigator is free to publish in reputable 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