Chronic Kidney Disease, Kidney Disease
Conditions
Keywords
Chronic Kidney Disease, Dialysis, Anemia, Nephrology
Brief summary
The purpose of this study is to determine whether darbepoetin alfa manufactured by the current roller bottle technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.
Interventions
DRUGdarbepoetin alfa SF
Frequency of dosing depends on frequency at randomization: rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis * Anemic * Currently on erythropoietic therapy * Controlled hypertension * Clinically stable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile | Entire Study |
Secondary
| Measure | Time frame |
|---|---|
| To characterize laboratory parameters in subjects with CKD | Entire Study |
Outcome results
None listed