INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)

NCT04932148 | Recruiting DMC

• 1 other identifier: AKTN 20.04
• Study Type: interventional
• Target: 372
• Locations: 2 countries
• Sites: 18

Brief Summary

The INCH-HD trial will test if incremental HD preserves the quality of life of patients and families and is a safe, practical, cost effective treatment option.

Conditions

Kidney Failure

Keywords

Incremental HD; Incident HD

Outcome Measures

Primary Outcomes (1)

• Heath related quality of life

  This will be measured using Kidney-specific component (KSC) of the Kidney Disease Quality of Life Short Form (KDQOL-SF) V1.3 questionnaire. The KSC is the mean of the 11 domains of the kidney-disease specific items of KDQOL-SF. Scores are transformed onto a 0-100 range, where a higher score reflects a better quality of life.

  6 months

Secondary Outcomes (16)

• Residual kidney function (RKF)

  Baseline, 3, 6, 12 and 18 months

• Healthcare resource utilisation

  Baseline to 18 months

• Healthcare costs

  Baseline to 18 months

• Heath related quality of life using Kidney Disease Quality of Life Short Form (KSQOL-SF) questionnaire

  Baseline, 3, 6, 9, 12, 15 and 18 months

• Heath related quality of life using EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire

  Baseline, monthly to 18 months

Other Outcomes (2)

• Patient lifestyle and wellbeing

  Baseline, 3, 6, 9, 12, 15 and 18 months

• Time to event

  Baseline to 18 months

Study Arms (2)

Incremental HD

EXPERIMENTAL

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.

Other: Incremental HD

Conventional HD

OTHER

Participants randomised to conventional HD will commence HD thrice weekly from the first HD session.

Other: Conventional HD

Interventions

Incremental HD OTHER

Starting haemodialysis at twice weekly frequency

Incremental HD

Conventional HD OTHER

Starting haemodialysis at thrice weekly frequency

Conventional HD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥ 18 years of age) and
• Commencing HD as their initial dialysis therapy and
• Able to give informed consent

You may not qualify if:

• Urine output \<0.5Litres/day
• Unlikely to be on HD for ≥1 year.

Sponsors & Collaborators

• The University of Queensland: lead
• Medical Research Future Fund: collaborator
• Queensland Health: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (18)

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

RECRUITING

Northern Beaches Hospital

Frenchs Forest, New South Wales, 2086, Australia

NOT YET RECRUITING

St George Hospital

Kogarah, New South Wales, 2217, Australia

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

RECRUITING

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

RECRUITING

Port Macquarie Hospital

Port Macquarie, New South Wales, 2444, Australia

RECRUITING

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

NOT YET RECRUITING

Bundaberg Hospital

Bundaberg, Queensland, Australia

RECRUITING

Cairns Hospital

Cairns, Queensland, Australia

RECRUITING

Redland Hospital

Cleveland, Queensland, 4163, Australia

NOT YET RECRUITING

Logan Hospital

Logan City, Queensland, 4131, Australia

RECRUITING

Toowoomba Hospital

Toowoomba, Queensland, 4350, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Monash Health

Melbourne, Victoria, 3168, Australia

RECRUITING

Eastern Health

Melbourne, Victoria, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, Washington, 6150, Australia

NOT YET RECRUITING

University Health Network- University of Toronto

Toronto, Ontario, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Peter Kerr, Prof

  University of Queensland, Monash University

  PRINCIPAL INVESTIGATOR

• David Johnson, Prof

  University of Queensland, Queensland Health

  PRINCIPAL INVESTIGATOR

• Andrea Viecelli, Dr

  University of Queensland, Queensland Health

  PRINCIPAL INVESTIGATOR

• Charmaine Lok, Prof

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisan Mulvey

CONTACT

+61 417 690 237; inch-hd.trial@uq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 18, 2021
• Study Start: July 6, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-04

Locations

AU (17); CA (1)