N/A
Completed N=124
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia
Source: ClinicalTrials.gov NCT01677767 ↗Enrolled (actual)
124
Serious AEs
4.8%
Results posted
Feb 2016
Primary outcomePrimary: Mean Age of Participants Treated With C.E.R.A — 48.1 Years
Summary
This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Age of Participants Treated With C.E.R.A |
48.1 | — |
| PRIMARY Mean Weight of Participants Treated With C.E.R.A |
57.44 | — |
| PRIMARY Number of Participants With Co-morbidity Treated With C.E.R.A |
107; 63; 61; 46 | — |
| PRIMARY Mean Time Required to Achieve Target Hemoglobin Range |
11.66 | — |
| PRIMARY Percentage of Participants Achieved Target Range of Hemoglobin |
74.7 | — |
| PRIMARY Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants. |
20 | — |
| SECONDARY Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study |
83 | — |
| SECONDARY Mean Time Spent by Participants in the Hb Target Range |
13.54 | — |
| SECONDARY Evaluation of Route of Administration for C.E.R.A |
11; 647 | — |
| SECONDARY Evaluation of Dose Per Injection of C.E.R.A |
64.0 | — |
| SECONDARY Number of Participants Received Concomitant Medications |
122 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, 18 to 65 years of age, inclusive
- Patients with chronic kidney disease on dialysis
- ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
- Adequate irons status as judged by the treating physician
Exclusion Criteria
- Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- Clinically significant concomitant disease or disorder as defined by protocol
- Clinical suspicion of pure red cell aplasia (PRCA)
- Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
- Transfusion of red blood cells in the previous 2 months
- Pregnant women
- Contraindications for Mircera according to local prescribing information or as judged by the investigator
Data sourced from ClinicalTrials.gov (NCT01677767). 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.