N/A
Completed N=98
An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis
Source: ClinicalTrials.gov NCT01940484 ↗Enrolled (actual)
98
Serious AEs
80.6%
Results posted
Apr 2016
Primary outcomePrimary: Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1) — 23 participants
Summary
This observational study will evaluate the efficacy and use of Methoxy polyethylene glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1) |
23 | — |
| PRIMARY Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2) |
26 | — |
| PRIMARY Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3) |
22 | — |
| PRIMARY Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4) |
17 | — |
| PRIMARY Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5) |
24 | — |
| PRIMARY Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6) |
24 | — |
| PRIMARY Mean Hemoglobin Value at Visit 2 (Month 1) |
11.31 | — |
| PRIMARY Mean Hemoglobin Value at Visit 3 (Month 2) |
10.81 | — |
| PRIMARY Mean Hemoglobin Value at Visit 4 (Month 3) |
10.61 | — |
| PRIMARY Mean Hemoglobin Value at Visit 5 (Month 4) |
10.80 | — |
| PRIMARY Mean Hemoglobin Value at Visit 6 (Month 5) |
10.82 | — |
| PRIMARY Mean Hemoglobin Value at Visit 7 (Month 6) |
10.94 | — |
| SECONDARY Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study |
106.59; 108.91; 117.38; 122.47; 127.35; 133.73 | — |
| SECONDARY Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta |
0; 0; 6; 4; 1; 7 | — |
| SECONDARY Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert |
— | — |
Eligibility Criteria
Inclusion Criteria
- Participants with chronic renal anemia with Stage V chronic kidney disease on hemodialysis and with a hemoglobin level of 10.0 - 13.0 grams per deciliter (g/dL)
- Participants had to be receiving an ESA prior to entering the study
- Female participants of childbearing age had to be using effective contraceptive methods
Exclusion Criteria
- As per approved package insert
- Any contraindication to ESA treatment
Data sourced from ClinicalTrials.gov (NCT01940484). 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.