Kidney Disease
Conditions
Keywords
Kidney disease, Renal, CKD (Chronic Kidney Disease), CRI (Chronic Renal Insufficiency), Pre-dialysis, Amgen, Aranesp®, Darbepoetin alfa, QW dosing, Q2W dosing, Q4W dosing, Patient preference, Subject preference
Brief summary
The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).
Interventions
DRUGAranesp®
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
- Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 12 weeks - Must currently be on a stable dose of Procrit® (defined as less than 25% change in Procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - Have Hgb 10-12 g/dL for at least 4 weeks prior to study start - Have 15 less than GFR less than 89 mL/min/1.73 m2 - Have serum vitamin B12 and folate levels above the lower limits of normal - Transferrin saturation greater than 20%
Exclusion criteria
- Currently receiving investigational erythropoietic agents - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subject preference | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject productivity and subject selection of Aranesp® or Procrit® therapy in the parallel arm portion and at study conclusion. | — |
Outcome results
None listed