Phase 3
N=351
A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00699348 ↗Enrolled (actual)
351
Serious AEs
27.9%
Results posted
Apr 2016
Primary outcome: Primary: Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range — 60.00 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Methoxy polyethylene glycol-epoetin beta (C.E.R.A.) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range |
60.00 | — |
| SECONDARY Change in Hemoglobin Concentration Between Reference SVP and EEP |
-0.10 | — |
| SECONDARY Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range |
73.94 | — |
| SECONDARY Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP |
44.0 | — |
| SECONDARY Percentage of Participants Requiring Any Dose Adjustment |
70.3; 50.9 | — |
| SECONDARY Number of Participants With Red Blood Cell Transfusion During the Study |
38 | — |
Summary
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent [ESA] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- Chronic renal anemia;
- Continuous intravenous maintenance erythropoietin stimulating agent (ESA) treatment during previous month;
- Regular long term hemodialysis therapy with the same mode of dialysis for >=3 months.
Exclusion Criteria
- Transfusion of red blood cells during previous 2 months;
- Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
- Active malignant disease (except non-melanoma skin cancer).
Data sourced from ClinicalTrials.gov (NCT00699348). 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.