Phase 3
N=228
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00442702 ↗Enrolled (actual)
228
Serious AEs
28.1%
Results posted
Oct 2011
Primary outcome: Primary: Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period — 11.29; 11.33; 0.15; -0.03 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mircera (Drug); Darbepoetin alfa (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period |
11.29; 11.33; 0.15; -0.03 | — |
| SECONDARY Change in Hemoglobin Concentration From Baseline Over Time |
11.27; 11.31; 0.29; 0.03; 0.34; 0.06 | — |
| SECONDARY Number of Participants With Red Blood Cell (RBC) Transfusions |
9; 3; 5; 1; 5; 2 | — |
| SECONDARY Participants With Adverse Events |
102; 88; 4; 3; 41; 23 | — |
Summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- chronic kidney disease, not requiring dialysis;
- receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.
Exclusion Criteria
- overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;
- transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
- active malignant disease;
- previous treatment with Mircera.
Data sourced from ClinicalTrials.gov (NCT00442702). 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.