Anemia
Conditions
Brief summary
This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Interventions
iv or sc, as prescribed
DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]
30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients \>=18 years of age; * chronic renal anemia; * on dialysis therapy for at least 12 weeks before screening; * receiving iv or sc epoetin for at least 8 weeks before screening.
Exclusion criteria
* women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of another investigational drug within 4 weeks before screening, or during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin concentration | Weeks 1-36 |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration | Weeks 29-36 |
| RBC transfusions | Weeks 1-36 |
| AEs, laboratory parameters, vital signs | Throughout study |
Countries
Canada, France, Germany, Italy, Poland, Portugal, Puerto Rico, Spain, Taiwan, Thailand, United Kingdom, United States
Outcome results
None listed