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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12609000615280 |
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Date of registration:
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22/07/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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FINESSE Trial – Filtration In the Neuropathy of End Stage kidney disease Symptom Evolution
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Scientific title:
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Haemodiafiltration vs high-flux standard dialysis for uraemic neuropathy in people with end stage kidney disease |
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Date of first enrolment:
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31/07/2009 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12609000615280.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Liz Haberecht
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Address:
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Statewide Renal Services
Building 12
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Australia |
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Telephone:
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+61 2 95153505 |
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Email:
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hometrain@email.cs.nsw.gov.au |
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Affiliation:
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Name:
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Meg Jardine
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Address:
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Statewide Renal Services
Renal Unit
4W
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Australia |
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Telephone:
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+61 2 97676447 |
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Email:
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mjardine@george.org.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Incident or prevalent patients requiring maintenance haemodialysis therapy for end stage kidney disease.
2. Aged 18 years or older
3. Suitable for either haemodiafiltration or standard dialysis in the view of the treating physician
4. Agreeable to randomisation
Exclusion criteria: Patients will be excluded if, in the opinion or knowledge of the responsible clinician:
1. Life expectancy is less than 6 months.
2. Definite plans to undergo renal transplantation, transfer to a non-study site, transfer to peritoneal dialysis or transfer to home haemodialysis within 12 months of entry to the study.
3. Unable or unwilling to complete neuropathy staging, including nerve conduction studies.
4. Receiving haemodiafiltration
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Renal and Urogenital - Kidney disease
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Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
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Uraemic neuropathy;End Stage Kidney Disease;
Uraemic neuropathy
End Stage Kidney Disease
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Intervention(s)
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Haemodiafiltration
Haemodiafiltration differs from conventional haemodialysis in employing convection as well as diffusion principles to remove solutes and excess water.
Participants will receive their routine haemodialysis hours and sessions (as prescribed by their treating nephrologist) with haemodiafiltration.
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Primary Outcome(s)
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Mean annual change in neuropathy as measured by the Total Neuropathy Score[12, 24, 36 and 48 months after randomisation]
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Secondary Outcome(s)
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Mean annual change in neuropathy as measured by the Neuropathy Symptom Score[12, 24, 36 and 48 months after randomisation]
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Safety as measured by:
a) Time to access failure, defined as thrombosis or fistula requiring revision
b) Number of discrete episodes of access failure, defined as above.
c) Episodes of septicaemia defined as blood culture positive septic episode with no defined focal source.
d) Difference in survival between the two groups[Continuous from baseline to 48 months after commencement of treatment. Survival will also be measured access to site Australia and New Zealand Dialyis and Transplant Registry (ANZDATA) data at 60 months.]
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Durability of the intervention (whether the patient remains on the assigned intervention)[Measured directly at 12, 24, 36 and 48 months after randomisation and at 60 months by site access to ANZDATA data.]
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Quality of life outcomes
Analyses will be performed in participants with sufficient language skills to self-complete a written questionnaire and will include:
a) Change in quality of life from baseline months as measured by the Kidney Disease Quality of Life (KDQOL-SF1.3) instrument
b) Change in quality of life from baseline as measured by the EurolQol (EQ-5D) instrument[6, 12, 18, 24, 30, 36, 42 and 48 months after randomisation]
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Source(s) of Monetary Support
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Statewide Renal Services
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Review Committee (Royal Prince Alfred Hospital (RPAH) Zone) of the Sydney South West Area Health Service
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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