Anemia
Conditions
Brief summary
This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not 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
DRUGdarbepoetin alfa
0.45 micrograms/kg sc (starting dose) weekly
DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]
0.6 micrograms/kg sc (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 kidney disease; * anemia; * not on dialysis therapy; * not receiving epoetin.
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 |
|---|---|
| Hemoglobin response rate | Weeks 1-28 |
Secondary
| Measure | Time frame |
|---|---|
| Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n | Throughout study |
Countries
Australia, Belgium, Canada, France, Germany, Greece, Italy, Netherlands, Puerto Rico, Spain, Sweden, United Kingdom, United States
Outcome results
None listed