Phase 4
N=191
A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00922116 ↗Enrolled (actual)
191
Serious AEs
16.2%
Results posted
Dec 2015
Primary outcome: Primary: Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP) — 53.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP) |
53.9 | — |
| SECONDARY Change in Hemoglobin Concentration Between SVP and the EEP |
0.55 | — |
| SECONDARY Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP |
73.0 | — |
| SECONDARY Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP |
87.2 | — |
| SECONDARY Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP |
103.6 | — |
| SECONDARY Average Dose of Mircera Per Month |
121.2; 100.8; 78.8; 72.7; 66.9; 66.2 | — |
Summary
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. 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;
- continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.
Exclusion Criteria
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease (except non-melanoma skin cancer).
Data sourced from ClinicalTrials.gov (NCT00922116). 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.