N/A
N=340
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis
Kidney Disease, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01318512 ↗Enrolled (actual)
340
Serious AEs
1.5%
Results posted
Dec 2015
Primary outcome: Primary: Average Dose of MIRCERA at Entry Level — 94 microgram (µg)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Dose of MIRCERA at Entry Level |
94 | — |
| PRIMARY Average Dose of MIRCERA During Titration Period Month 1 |
101.3 | — |
| PRIMARY Average Dose of MIRCERA During Titration Period Month 2 |
102.4 | — |
| PRIMARY Average Dose of MIRCERA During Titration Period Month 3 |
106.1 | — |
| PRIMARY Average Dose of MIRCERA During Titration Period Month 4 |
107.5 | — |
| PRIMARY Average Dose of MIRCERA During Maintenance Period Month 1 |
105 | — |
| PRIMARY Average Dose of MIRCERA During Maintenance Period Month 2 |
106 | — |
| PRIMARY Average Dose of MIRCERA During Maintenance Period Month 3 |
107 | — |
| PRIMARY Average Dose of MIRCERA During Maintenance Period Month 4 |
109 | — |
| PRIMARY Average Dose of MIRCERA During Maintenance Period Month 5 |
112 | — |
| PRIMARY Average Dose of MIRCERA During Maintenance Period Month 6 |
114 | — |
| SECONDARY The Mean Hemoglobin (Hb) Level During Titration Period |
93.9; 98.4; 103.4; 106.3; 108.4 | — |
| SECONDARY The Mean Hemoglobin (Hb) Level During Maintenance Period |
109.3; 110.3; 111.2; 112.1; 112.5; 113.8 | — |
Summary
This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.
Eligibility Criteria
Inclusion Criteria
- Adults patients, >/=18 years of age
- Presence of chronic kidney disease (Stage 3-4)
Exclusion Criteria
- Participation in another clinical study
Data sourced from ClinicalTrials.gov (NCT01318512). 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.