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

May 10, 2026 updated by: The University of Queensland

The INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD) Study: a Randomised Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Kidney failure is a growing public health problem and fatal unless treated with dialysis or transplantation. Haemodialysis is the most common treatment for kidney failure in Australia and globally. Patients find haemodialysis extremely burdensome due to symptoms like fatigue, pain, cramps and poor quality of life that generally equates to <60% of full health. Furthermore, haemodialysis is associated with an extremely high mortality (<50% survive 5 years), particularly in the first 3-6 months of starting haemodialysis, which is likely linked to the rapid loss of patients' own kidney function when starting haemodialysis abruptly at three sessions/week. Observational studies suggest that starting haemodialysis incrementally at two sessions/ week is associated with lower mortality and better preservation of patients' remaining kidney function while offering many patient-important advantages, including dialysis free time and ability to work. However, robust evidence to recommend this incremental approach is lacking.

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.

Study Type

Interventional

Enrollment (Estimated)

372

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Contact:
        • Principal Investigator:
          • Shaundeep Sen, Dr
      • Frenchs Forest, New South Wales, Australia, 2086
        • Not yet recruiting
        • Northern Beaches Hospital
        • Contact:
          • John-Paul Killen
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • St George Hospital
        • Contact:
          • Brendan Smyth
      • Liverpool, New South Wales, Australia, 2170
      • New Lambton Heights, New South Wales, Australia, 2305
      • Port Macquarie, New South Wales, Australia, 2444
      • Saint Leonards, New South Wales, Australia, 2065
    • Queensland
      • Bundaberg, Queensland, Australia
        • Recruiting
        • Bundaberg Hospital
        • Contact:
          • Clyson Mutatiri, Dr
      • Cairns, Queensland, Australia
        • Recruiting
        • Cairns Hospital
        • Contact:
          • Chetana Naresh, Dr
      • Cleveland, Queensland, Australia, 4163
        • Not yet recruiting
        • Redland Hospital
        • Contact:
          • David Mudge, Dr
      • Logan City, Queensland, Australia, 4131
        • Recruiting
        • Logan Hospital
        • Contact:
          • Vinod Khelgi, Dr
      • Toowoomba, Queensland, Australia, 4350
      • Woolloongabba, Queensland, Australia, 4102
    • South Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
        • Contact:
          • Peter Kerr
      • Melbourne, Victoria, Australia
        • Recruiting
        • Eastern Health
        • Contact:
          • Matthew Roberts
    • Washington
      • Murdoch, Washington, Australia, 6150
        • Not yet recruiting
        • Fiona Stanley Hospital
        • Contact:
          • Ramyasuda Swaminathan
  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • University Health Network- University of Toronto
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Incremental HD
Starting haemodialysis at twice weekly frequency
Other: Conventional HD
Participants randomised to conventional HD will commence HD thrice weekly from the first HD session.
Other: Conventional HD
Starting haemodialysis at thrice weekly frequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heath related quality of life
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual kidney function (RKF)
Time Frame: Baseline, 3, 6, 12 and 18 months

Calculated as (creatinine clearance + kidney urea clearance) divided by 2 then corrected for body surface area using the DuBois method (0.20247 x (height in centimetres x 0.725) x (weight in kilograms x 0.425).

Expressed as millilitres per minute (ml/min). Expected range 1 ml/min to 20 ml/min, where lower values indicate worse kidney function.
Baseline, 3, 6, 12 and 18 months
Healthcare resource utilisation
Time Frame: Baseline to 18 months
Healthcare resource use over 18 months using linked data and patient monthly calendars
Baseline to 18 months
Healthcare costs
Time Frame: Baseline to 18 months
Healthcare costs over 18 months using linked data and patient monthly calendars
Baseline to 18 months
Heath related quality of life using Kidney Disease Quality of Life Short Form (KSQOL-SF) questionnaire
Time Frame: Baseline, 3, 6, 9, 12, 15 and 18 months
Heath-related quality of life 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.
Baseline, 3, 6, 9, 12, 15 and 18 months
Heath related quality of life using EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire
Time Frame: Baseline, monthly to 18 months
Heath-related quality of life will be measured using EuroQol 5 Domain 5 Level (EQ-5D-5L) questionnaire. EQ-5D has descriptive and visual analogue scale (VAS). Descriptive system consists of five dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. VAS records patient's self-rated health on vertical visual analogue scale with endpoints best to worst health with 0 being worst and 100 being best health.
Baseline, monthly to 18 months
Incidence of all-cause mortality
Time Frame: Baseline to 18 months
Incidence of all-cause mortality up to 18 months
Baseline to 18 months
Time to major cardiovascular event (MACE)
Time Frame: Baseline to 18 months
Time to first major cardiovascular event (MACE) up to 18 months
Baseline to 18 months
Number of non-elective hospital admissions
Time Frame: Baseline to 18 months
Number of non-elective hospital admissions up to 18 months
Baseline to 18 months
Total hospital days
Time Frame: Baseline to 18 months
Total hospital days up to 18 months
Baseline to 18 months
Time to death
Time Frame: Baseline to 18 months
Time to death up to 18 months
Baseline to 18 months
Number of hospital admissions
Time Frame: Baseline to 18 months
Number of hospital admissions up to 18 months
Baseline to 18 months
Adverse events and side-effects
Time Frame: Baseline to 18 months
This will include episodes of hyperkalaemia, extra dialysis sessions for fluid overload, number of vascular access complications
Baseline to 18 months
Symptom scores
Time Frame: Baseline, 3, 6, 9, 12, 15 and 18 months
This will be measured using change in the physical and mental component summaries of the Kidney Disease Quality of Life Short Form (KDQOL-SF) V1.3 questionnaire. This is scored using the mean of the physical and mental components of the KDQOL-SF. Scores are transformed onto a 0-100 range, where a higher score reflects a better quality of life.
Baseline, 3, 6, 9, 12, 15 and 18 months
Fatigue
Time Frame: Baseline, 3, 6, 9, 12, 15 and 18 months
This will be measured using the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) Fatigue questionnaire. The SONG-HD Fatigue measure consists of three items that assess the effect of fatigue on life participation, tiredness, and level of energy. The overall score for fatigue is obtained by summing the responses across the three questions, resulting in a scale ranging from zero (no fatigue) to nine (maximum fatigue).
Baseline, 3, 6, 9, 12, 15 and 18 months
Nutritional Status
Time Frame: Baseline, 6, 12 and 18 months
This will be measured using the Subjective Global Assessment (SGA) of nutrition which is scored as proportion of well nourished (A) versus malnourished (B or C). A (well nourished), B (mildly-moderately malnourished), C (Severely malnourished)
Baseline, 6, 12 and 18 months
Vascular access
Time Frame: Baseline to 18 months
This will be measured as mumber of functional vascular access interventions required per patient per year to enable and /or maintain vascular access for HD per patient-year
Baseline to 18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient lifestyle and wellbeing
Time Frame: Baseline, 3, 6, 9, 12, 15 and 18 months
This will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) SF 4a (Ability to Participate in Social Roles and Activities and Satisfaction with Social Roles and Activities)
Baseline, 3, 6, 9, 12, 15 and 18 months
Time to event
Time Frame: Baseline to 18 months
Time to trigger condition being met in Incremental HD patients (date the trigger condition/s were met) and subsequent time to transition to 3x/week HD
Baseline to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Queensland

Collaborators

Canadian Institutes of Health Research (CIHR)
Queensland Health
Medical Research Future Fund

Investigators

  • Principal Investigator: Peter Kerr, Prof, University of Queensland, Monash University
  • Principal Investigator: Andrea Viecelli, Dr, University of Queensland, Queensland Health
  • Principal Investigator: Charmaine Lok, Prof, University Health Network, Toronto
  • Principal Investigator: David Johnson, Prof, University of Queensland, Queensland Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKTN 20.04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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