N/A
N=780
A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta)
Anemia, Kidney Disease, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01379963 ↗Enrolled (actual)
780
Serious AEs
—
Results posted
Dec 2015
Primary outcome: Primary: Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL) — 17.18 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL) |
17.18 | — |
| SECONDARY Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL |
3.09 | — |
Summary
This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Renal anemia treated with Mircera for at least 6 months before entering study
Exclusion Criteria
- Patients who refuse or are incapable of giving their written informed consent to retrospective data collection
Data sourced from ClinicalTrials.gov (NCT01379963). 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.