N/A
Completed N=437
OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis
Source: ClinicalTrials.gov NCT01902628 ↗Enrolled (actual)
437
Serious AEs
12.8%
Results posted
Aug 2018
Primary outcomePrimary: Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10 — 51.2 percentage of participants
Summary
This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia. Participants initiated on treatment with Mircera according to the Summary of Product Characteristics and standard clinical practice were followed for 10 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10 |
51.2 | — |
| SECONDARY Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10 |
68.8; 35.4; 53 | — |
| SECONDARY Percentage of Participants With MIRCERA Dose Adjustments |
13; 12.4; 10.6; 11; 11.6; 10.2 | — |
| SECONDARY Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs |
56; 37 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 & 4)
- Initiated on Mircera treatment (participants may have received Mircera treatment for up to 3 months before study enrollment)
- Life expectancy > 10 months
Exclusion Criteria
- Malignant disease
- Significant or acute bleeding
- Poorly controlled hypertension
- Blood transfusion during the previous 2 months
- Hypersensitivity to Mircera or any of its excipients
Data sourced from ClinicalTrials.gov (NCT01902628). 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.