None listed
Conditions
Brief summary
The majority of patients with kidney failure have anaemia requiring erythropoietin therapy administered either subcutaneously or intravenously. Darbepoetin is a type of erythropoietin, which can be given via the subcutaneous or intravenous route. In patients prescribed subcutaneous darbepoetin, pain during and at the site of injection are common complaints. The aim of this study is to determine the differences in patients’ perceptions in the administration and pain between pre-filled syringe and pre-filled pen darbepoetin in patients already on subcutaneous pre-filled syringe darbepoetin therapy.
Interventions
Darbepoetin pre-filled syringer compared to sureclick delivery systems
1. The amount of darbepoetin will be variable according to their usual dosing (range can be from 20mcg 1 to 3 weekly to 200mcg weekly or 1 to 3 weekly).
2. The times and duration of treatment will be variable according to the usual regimen i.e. the participation in this study will not alter the dose and duration of the injections.
3. Cross-over non-drug trial (i.e. darbepoetin is the only drug). The participants will be requi
Darbepoetin pre-filled syringer compared to sureclick delivery systems 1. The amount of darbepoetin will be variable according to their usual dosing (range can be from 20mcg 1 to 3 weekly to 200mcg weekly or 1 to 3 weekly). 2. The times and duration of treatment will be variable according to the usual regimen i.e. the participation in this study will not alter the dose and duration of the injections. 3. Cross-over non-drug trial (i.e. darbepoetin is the only drug). The participants will be required to use one device for 4 injections, followed by the alternative device for 4 injections, followed by the first device for another 4 injections. All injections will be taken one after the other according to their treatment regimen. 4. The intervention in this trial will be self-administered by the participants.
Sponsors
Health Department of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with chronic kidney disease already maintained on darbepoetin injections and deemed capable of device training and completion of a questionnaire
Exclusion criteria
Patients who are unable to self-administer subcutaneously, unable to be trained on administration technique or incapable of giving informed consent will be excluded.
Outcome results
None listed