N/A
Completed N=223
Observational Study of Methoxy Polyethylene Glycol Epoetin Beta Daily Use in Participants on Peritoneal Dialysis
Renal impairment · Renal Anemia of Chronic Kidney Disease
Source: ClinicalTrials.gov NCT02596945 ↗
Enrolled (actual)
223
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: 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
Summary
This non-interventional, observational study investigates the efficacy, safety and usability of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis. Participants who were prescribed methoxy polyethylene glycol epoetin beta by their doctor and who meet the selection criteria were to be enrolled and documented in this study for a period of 9 months of treatment with methoxy polyethylene glycol epoetin beta with respect to efficacy, safety and usability.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 | — |
| SECONDARY 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 | — |
| SECONDARY Average Duration in Days Mircera Was Administered at a Stable Dose |
182.1 | — |
Eligibility Criteria
Inclusion Criteria
- Participants on peritoneal dialysis
- Need for Erythropoiesis Stimulating Agent (ESA) therapy
- Prescription of methoxy polyethylene glycol epoetin beta by the doctor
Exclusion Criteria
N/A
Data sourced from ClinicalTrials.gov (NCT02596945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.