N/A
Completed N=1,580
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia
Source: ClinicalTrials.gov NCT01051323 ↗Enrolled (actual)
1,580
Serious AEs
4.8%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range — 97.9; 72.9; 33.7; 35.3 percentage of participants
Summary
This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. Data from each patient will be collected over 12 months of Mircera therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range |
97.9; 72.9; 33.7; 35.3 | — |
| PRIMARY Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size |
11.5; 8.7; 0.6; 0.8; 11.5; 11.2 | — |
| PRIMARY Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size |
9.6; 12.8; 3.2; 2.5; 8.3; 12.8 | — |
| PRIMARY Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size |
1.3; 1.6; 1.6; 1.5; 1.5; 1.6 | — |
| PRIMARY Serum Ferritin Values |
402.5; 526.5; 479.9; 412.6; 517.4; 518.2 | — |
| PRIMARY Serum Iron Values |
73.3; 69.5; 68.8; 74.5; 67.7; 68.9 | — |
| PRIMARY Transferrin Values |
196.1; 187.9; 192.5; 192.6; 187.7; 193.6 | — |
| PRIMARY Transferrin Saturation Values |
24.4; 27.3; 26.7; 28.0; 26.4; 27.5 | — |
| PRIMARY C-reactive Protein (CRP) Values |
13.3; 15.0; 12.9; 21.6; 14.5; 12.1 | — |
| PRIMARY Number of Physicians Satisfied With Treatment at Final Visit |
685; 602; 136; 31; 56 | — |
| PRIMARY Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion |
944; 490; 76 | — |
| PRIMARY Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion |
24; 177; 1; 5; 10; 116 | — |
| PRIMARY Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy |
30; 1; 21; 50; 46; 21 | — |
| PRIMARY Number of Participants Satisfied With Treatment at Final Visit |
593; 713; 114; 16; 74 | — |
| SECONDARY Average Methoxy Polyethylene Glycol-epoetin Beta Dose |
109.1; 121.8; 124.6; 126.2; 129.4; 130.5 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >/= 18 years of age
- chronic kidney disease
- informed consent for data transmission
Exclusion Criteria
- serious hematological or infectious disease
- acute bleeding in the 16 weeks preceding data collection
- participation in an interventional trial
- female patients: pregnancy or breast-feeding
Data sourced from ClinicalTrials.gov (NCT01051323). 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.