Phase 4
N=35
A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00642668 ↗Enrolled (actual)
35
Serious AEs
44.1%
Results posted
Jul 2016
Primary outcome: Primary: Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range — 41 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- methoxy polyethylene glycol-epoetin beta (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range |
41 | — |
| SECONDARY Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP) |
0.99 | — |
| SECONDARY Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP) |
23.5 | — |
| SECONDARY Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP) |
28.6 | — |
| SECONDARY Percentage of Participants With Adverse Events |
97 | — |
Summary
This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.
Eligibility Criteria
Inclusion Criteria
- Adult participants, >=18 years of age;
- Chronic renal anemia;
- No ESA therapy during previous 3 months.
Exclusion Criteria
- Transfusion of red blood cells during previous 2 months;
- Poorly controlled hypertension requiring hospitalization in previous 6 months;
- Significant acute or chronic bleeding.
Data sourced from ClinicalTrials.gov (NCT00642668). 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.