Anemia
Conditions
Brief summary
This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin alfa (Aranesp) in patients with renal anemia. Eligible patients will be randomized to receive comparable subcutaneous injections of either darbepoetin alfa (30 micrograms) or NeoRecormon (6000IU). They will then be crossed over to the alternative treatment arm for further treatment. After each injection pain will be assessed using the visual analogue scale (VAS) and 6-point verbal rating scale (VRS), and patient preference will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Interventions
DRUGdarbepoetin alfa
30 micrograms sc weekly (2 doses)
6000 IU sc weekly (2 doses)
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>18 years of age; * patients with renal anemia or post-transplant anemia.
Exclusion criteria
* poorly controlled hypertension; * known hypersensitivity to NeoRecormon or darbepoetin alfa.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local pain due to s.c. injection (by VAS). | After each injection |
Secondary
| Measure | Time frame |
|---|---|
| Patient preference. | At end of study |
| AEs, vital signs. | Throughout study |
Countries
Australia
Outcome results
None listed