Anemia
Conditions
Brief summary
This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
DRUGEpoetin beta
As prescribed, 3 times weekly
DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]
0.4 micrograms/kg iv 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 requiring dialysis; * maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before and during screening; * adequate iron status.
Exclusion criteria
* previous epoetin treatment within 8 weeks prior to screening; * failing renal graft in place; * bleeding episode necessitating transfusion within 8 weeks prior to screening; * poorly controlled hypertension; * previous treatment with Mircera.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hb response rate | Weeks 0-24 |
| Change in Hb concentration between baseline and evaluation period | Months 4-6 |
Secondary
| Measure | Time frame |
|---|---|
| RBC transfusions | Weeks 0-24 |
| Hb over time | Throughout study |
| Serum concentration of Mircera | Throughout study |
| AEs, laboratory parameters, vital signs | Throughout study |
| Time to Hb response | Throughout study |
Countries
China, Hong Kong
Outcome results
None listed