Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000839909
Ethics application status
Approved
Date submitted
7/05/2009
Date registered
9/08/2011
Date last updated
9/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Perception of Darbepoetin Subcutaneous Delivery Systems
Scientific title
Chronic Kidney Disease Patients’ Perceptions On Subcutaneous Darbepoetin Delivery Systems – Pre-filled Syringe Compared To Pre-filled Sureclick Pen
Secondary ID [1] 262437 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain perception of injectable medication 4731 0
Chronic kidney disease 270511 0
Condition category
Condition code
Renal and Urogenital 237060 237060 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 4503 0
Treatment: Devices
Comparator / control treatment
Active - sureclick delivery system
Control group
Active

Outcomes
Primary outcome [1] 5900 0
Participants' preference and recommendation for device following completion of study
Timepoint [1] 5900 0
Baseline questionnaire followed by further 3 questionnaires (each questionnaire administered following 4 injections of a delivery system)
Secondary outcome [1] 241945 0
Subjective assessment of discomfort related to injection, ease of administration and as assessed by visual analogue scale
Timepoint [1] 241945 0
Baseline questionnaire followed by further 3 questionnaires (each questionnaire administered following 4 injections of a delivery system)

Eligibility
Key inclusion criteria
Patients with chronic kidney disease already maintained on darbepoetin injections and deemed capable of device training and completion of a questionnaire
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomised to commence therapy with one of the two devices by the use of treatment assignment envelopes. Consecutively numbered treatment envelopes will be held by the study nurse. After eligibility is confirmed and the subject is enrolled, the next consecutively numbered envelope will be opened to reveal the treatment assignment. The treatment assignment will be recorded and the subject will then begin the appropriate treatment sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4911 0
Commercial sector/Industry
Name [1] 4911 0
Amgen Australia Pty Ltd
Country [1] 4911 0
Australia
Primary sponsor type
Government body
Name
Health Department of Western Australia
Address
189 Royal Street
East Perth WA 6004
Country
Australia
Secondary sponsor category [1] 4440 0
None
Name [1] 4440 0
Address [1] 4440 0
Country [1] 4440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6974 0
Sir Charles Gairdner Hospital Group
Ethics committee address [1] 6974 0
Sir Charles Gairdner Hospital
Hospital Avenue,
NEDLANDS WA 6009
Ethics committee country [1] 6974 0
Australia
Date submitted for ethics approval [1] 6974 0
01/05/2009
Approval date [1] 6974 0
01/07/2009
Ethics approval number [1] 6974 0
2009-066

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29579 0
Address 29579 0
Country 29579 0
Phone 29579 0
Fax 29579 0
Email 29579 0
Contact person for public queries
Name 12826 0
Wai Hon Lim
Address 12826 0
Dept Renal Medicine
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Country 12826 0
Australia
Phone 12826 0
+61 8 9346 2799
Fax 12826 0
+61 8 9346 3942
Email 12826 0
[email protected]
Contact person for scientific queries
Name 3754 0
Wai Hon Lim
Address 3754 0
Dept Renal Medicine
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Country 3754 0
Australia
Phone 3754 0
+61 8 9346 2799
Fax 3754 0
+61 8 9346 3942
Email 3754 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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