Phase 3
N=489
A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00394953 ↗Enrolled (actual)
489
Serious AEs
39.5%
Results posted
Jan 2017
Primary outcome: Primary: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period — 64.1; 40.4 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Darbepoetin alfa (Drug); methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period |
64.1; 40.4 | <0.0001 sig |
| SECONDARY Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time |
6.8; 58.8 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormality Over Time |
1; 5; 18; 5; 4; 7 | — |
| SECONDARY Median Blood Pressure Over Time |
75; 70; 73; 71; 70; 70 | — |
| SECONDARY Mean Pulse Rate Over Time |
73; 73; 74; 72; 73; 71 | — |
| SECONDARY Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths |
222; 217; 99; 94; 14; 14 | — |
Summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. 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 renal anemia;
- hemodialysis 3 times weekly for >=12 weeks before screening, and during screening/baseline period;
- 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 malignancy;
Data sourced from ClinicalTrials.gov (NCT00394953). 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.