N/A
Completed N=185
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis
Anemia, Kidney Disease, Chronic
Source: ClinicalTrials.gov NCT01422824 ↗
Enrolled (actual)
185
Serious AEs
12.0%
Results posted
Mar 2016
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 49; 22 participants
Summary
This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving once monthly Mircera according to standard of care and local labelling during 12 months of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
49; 22 | — |
| SECONDARY Hemoglobin Levels |
110.3; 110.8; 111.3; 111.2; 111.2 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Stage IV chronic kidney disease, on haemodialysis
- Chronic renal anemia, on maintenance ESA treatment
- Hemoglobin concentration between 10.0 an 12 g/dL
- Continuous maintenance epoetin therapy with the same dosing interval during the previous month
Exclusion Criteria
- Contraindications to ESA treatment (e.g. hypersensitivity, non-controlled hypertension)
- Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
- Anemia due to hemolysis, pure red cell aplasia
Data sourced from ClinicalTrials.gov (NCT01422824). 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.