Status:
COMPLETED
A Clinical Trial of IntensiVE Dialysis
Lead Sponsor:
The George Institute
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Baxter Healthcare Corporation
Conditions:
Renal Replacement Therapy
Renal Dialysis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will assess clinical outcomes of extended weekly hours of haemodialysis (\>= 24 hours per week) compared with standard hours of haemodialysis (\<=18 hours/week) in people with ESKD.
Detailed Description
A rapidly increasing volume of observational data suggests substantial benefits may be associated with an increased duration of dialysis. As well as improved quality of life, improved functioning and ...
Eligibility Criteria
Inclusion
- Incident or prevalent patients requiring maintenance haemodialysis therapy for ESKD
- Aged 18 years or older
- Undergoing dialysis for 18 hours per week or less
- Suitable for either extended or standard dialysis in the view of the treating physician
- Agreeable to randomisation
Exclusion
- Life expectancy of less than 6 months
- Definite plans to undergo renal transplantation within 12 months of entry to the study
- Inability to complete quality of life questionnaire
- Concomitant major illness that would limit assessments and followup
- High chance that the patient will not adhere to study treatment and follow up in the view of the treating physician.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00649298
Start Date
May 1 2008
End Date
October 1 2014
Last Update
December 3 2019
Active Locations (40)
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1
The Canberra Hospital
Canberra, Australian Capital Territory, Australia
2
RPAH/Concord
Sydney, New South Wales, Australia, 2050
3
Sydney Adventist Hospital
Sydney, New South Wales, Australia, 2076
4
Liverpool Hospital
Sydney, New South Wales, Australia