Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00382044




Registration number
NCT00382044
Ethics application status
Date submitted
27/09/2006
Date registered
28/09/2006
Date last updated
23/05/2008

Titles & IDs
Public title
Audit of the Effect of Changing From IV to SC Administration of ESA's in Haemodialysis Patients
Scientific title
Audit of the Effect of Changing From IV to SC Administration of Erythropoiesis Stimulating Agents in Haemodialysis Patients - Real Life Clinical Experience
Secondary ID [1] 0 0
NB-06-10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure, Chronic 0 0
Anemia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Eprex; Neorecormon; Aranesp

Treatment: Drugs: Eprex; Neorecormon; Aranesp
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- On haemodialysis at a Sir Charles Gairdner Hospital Unit
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Sir Charles Gairdner Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to audit the effects of changing all hemodialysis patients from
intravenous to subcutaneous administration of ESA's, to ensure that a cost-saving is achieved
and that this does not occur at the expense of anemia control. The dose changes will occur
according to usual clinical care of patients and not along a protocol.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00382044
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neil C Boudville, MBBS
Address 0 0
Sir Charles Gairdner Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries