Anemia
Conditions
Brief summary
This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Interventions
DRUGepoetin
3 times a week iv, as prescribed.
DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]
0.4 micrograms/kg iv (starting dose) once 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; * dialysis therapy for at least 2 weeks before screening.
Exclusion criteria
* women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of any investigational drug within 4 weeks before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin response rate | Weeks 1-24 |
Secondary
| Measure | Time frame |
|---|---|
| Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n | Throughout study |
Countries
Brazil, Canada, Czechia, Greece, Norway, Poland, Russia, South Africa, Spain, Sweden, Switzerland, Thailand, United States
Outcome results
None listed