INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)
NCT ID: NCT04932148
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
372 participants
INTERVENTIONAL
2022-07-06
2026-08-31
Brief Summary
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Detailed Description
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The INCH-HD study is an investigator-initiated, international, multicentre, prospective, adaptive, randomised, open-label, parallel group, non-inferiority trial. The primary objective of the study is to demonstrate whether incremental HD is non-inferior to conventional HD for the patient-important outcome of quality of life measured using Kidney-specific component of the Kidney Disease Quality of Life - Short Form measurement (KDQOL-SF) at 6 months from dialysis commencement.
The study will recruit a total of 372 participants across HD centres in Australia, and Canada. The outcomes of this trial will will provide urgently needed high quality evidence on whether starting haemodialysis incrementally at two sessions/week compared to the conventional three sessions/week can safely reduce the physical, financial and quality-of life burden on patients, lower early mortality rates and slow loss of kidney function while increasing haemodialysis capacity and reducing costs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Incremental HD
Participants randomised to incremental HD will commence HD twice weekly and continue until an indication for an increase to three sessions/week (trigger point) is reached.
Incremental HD
Starting haemodialysis at twice weekly frequency
Conventional HD
Participants randomised to conventional HD will commence HD thrice weekly from the first HD session.
Conventional HD
Starting haemodialysis at thrice weekly frequency
Interventions
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Incremental HD
Starting haemodialysis at twice weekly frequency
Conventional HD
Starting haemodialysis at thrice weekly frequency
Eligibility Criteria
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Inclusion Criteria
2. Commencing HD as their initial dialysis therapy and
3. Able to give informed consent
Exclusion Criteria
2. Unlikely to be on HD for ≥1 year.
18 Years
ALL
No
Sponsors
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Medical Research Future Fund
OTHER
Queensland Health
OTHER_GOV
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
The University of Queensland
OTHER
Responsible Party
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Principal Investigators
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Peter Kerr, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Queensland, Monash University
David Johnson, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Queensland, Queensland Health
Andrea Viecelli, Dr
Role: PRINCIPAL_INVESTIGATOR
University of Queensland, Queensland Health
Charmaine Lok, Prof
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Concord Repatriation General Hospital
Concord, New South Wales, Australia
Northern Beaches Hospital
Frenchs Forest, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Bundaberg Hospital
Bundaberg, Queensland, Australia
Cairns Hospital
Cairns, Queensland, Australia
Redland Hospital
Cleveland, Queensland, Australia
Logan Hospital
Logan City, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Health
Melbourne, Victoria, Australia
Eastern Health
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
University Health Network- University of Toronto
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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John-Paul Killen
Role: primary
Brendan Smyth
Role: primary
Clyson Mutatiri, Dr
Role: primary
Chetana Naresh, Dr
Role: primary
David Mudge, Dr
Role: primary
Vinod Khelgi, Dr
Role: primary
Peter Kerr
Role: primary
Matthew Roberts
Role: primary
Ramyasuda Swaminathan
Role: primary
Other Identifiers
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AKTN 20.04
Identifier Type: -
Identifier Source: org_study_id
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