Kidney FailureNCT04932148
INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)
A study testing Incremental HD and Conventional HD in people with Kidney Failure, run by The University of Queensland at 18 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure
- What is being tested?
- Incremental HD and Conventional HD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 6 Jul 2022to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥ 18 years of age) and
- Commencing HD as their initial dialysis therapy and
- Able to give informed consent
Who cannot join
- Urine output <0.5Litres/day
- Unlikely to be on HD for ≥1 year.
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
Australia17 sites, 17 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Randall Faull, PI, randall.faull@sa.gov.au
Bronwyn Hockley, SC, 08 - 7074 3077, bronwyn.hockley@sa.gov.au
- Recruiting
Bundaberg Hospital
Bundaberg, Queensland
Clyson Mutatiri, Dr
- Recruiting
Cairns Hospital
Cairns, Queensland
Chetana Naresh, Dr
- Not yet recruiting
Redland Hospital
Cleveland, Queensland, 4163
David Mudge, Dr
- Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Shaundeep Sen, Dr, 02 9767 6447, Shaundeep.Sen@health.nsw.gov.au
Shaundeep Sen, Dr
- Not yet recruiting
Northern Beaches Hospital
Frenchs Forest, New South Wales, 2086
John-Paul Killen
- Recruiting
St George Hospital
Kogarah, New South Wales, 2217
Brendan Smyth
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2170
Angela Makris, Dr, angela.makris@health.nsw.gov.au
Angela Makris, Dr
- Recruiting
Logan Hospital
Logan City, Queensland, 4131
Vinod Khelgi, Dr
- Recruiting
Monash Health
Melbourne, Victoria, 3168
Peter Kerr
- Recruiting
Eastern Health
Melbourne, Victoria
Matthew Roberts
- Not yet recruiting
Fiona Stanley Hospital
Murdoch, Washington, 6150
Ramyasuda Swaminathan
- Recruiting
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Denise Jones, 02 4921 4332, Denise.jones@health.nsw.gov.au
Melissa Mulholland, 02 4921 4332, Melissa.Mulholland@health.nsw.gov.au
- Recruiting
Port Macquarie Hospital
Port Macquarie, New South Wales, 2444
Lin Lin Myat, (02) 5524 2000, linlin.myat@health.nsw.gov.au
- Not yet recruiting
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
Emma O'Lone, Dr, emma.olone@health.nsw.gov.au
- Recruiting
Toowoomba Hospital
Toowoomba, Queensland, 4350
Sridevi Govindarajulu, (07) 4616 6000, Sridevi.Govindarajulu@health.qld.gov.au
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Andrea Viecelli, Dr, Andrea.Viecelli@health.qld.gov.au
Canada1 site, 1 recruiting
- Not yet recruiting
University Health Network- University of Toronto
Toronto, Ontario
Charmaine Lok, charmaine.lok@uhn.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Failure
- Being tested
- Incremental HD, Conventional HD
- Keywords
- Incremental HD, Incident HD
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental HDOther
Starting haemodialysis at twice weekly frequency
Conventional HDOther
Starting haemodialysis at thrice weekly frequency
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Incremental HD |
| Conventional HD | Other | Participants randomised to conventional HD will commence HD thrice weekly from the first HD session. Receives: Other: Conventional HD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (16)
Residual kidney function (RKF)
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.
Measured: Baseline, 3, 6, 12 and 18 months
Healthcare resource utilisation
Healthcare resource use over 18 months using linked data and patient monthly calendars
Measured: Baseline to 18 months
Healthcare costs
Healthcare costs over 18 months using linked data and patient monthly calendars
Measured: Baseline to 18 months
Heath related quality of life using Kidney Disease Quality of Life Short Form (KSQOL-SF) questionnaire
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.
Measured: Baseline, 3, 6, 9, 12, 15 and 18 months
Heath related quality of life using EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire
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.
Measured: Baseline, monthly to 18 months
Incidence of all-cause mortality
Incidence of all-cause mortality up to 18 months
Measured: Baseline to 18 months
Time to major cardiovascular event (MACE)
Time to first major cardiovascular event (MACE) up to 18 months
Measured: Baseline to 18 months
Number of non-elective hospital admissions
Number of non-elective hospital admissions up to 18 months
Measured: Baseline to 18 months
Total hospital days
Total hospital days up to 18 months
Measured: Baseline to 18 months
Time to death
Time to death up to 18 months
Measured: Baseline to 18 months
Number of hospital admissions
Number of hospital admissions up to 18 months
Measured: Baseline to 18 months
Adverse events and side-effects
This will include episodes of hyperkalaemia, extra dialysis sessions for fluid overload, number of vascular access complications
Measured: Baseline to 18 months
Symptom scores
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.
Measured: Baseline, 3, 6, 9, 12, 15 and 18 months
Fatigue
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).
Measured: Baseline, 3, 6, 9, 12, 15 and 18 months
Nutritional Status
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)
Measured: Baseline, 6, 12 and 18 months
Vascular access
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
Measured: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start6 Jul 2022
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Future Fund, Queensland Health, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Peter Kerr, Prof, Principal investigator, University of Queensland, Monash UniversityDavid Johnson, Prof, Principal investigator, University of Queensland, Queensland HealthAndrea Viecelli, Dr, Principal investigator, University of Queensland, Queensland HealthCharmaine Lok, Prof, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932148
- Sponsor's protocol ID
- AKTN 20.04
- Status last verified
- Apr 2026
- First submitted
- 8 Jun 2021
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD) Study: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04932148
- Acronym / sponsor ID
- AKTN 20.04
- Conditions
- Kidney Failure
- Keywords
- Incremental HD, Incident HD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Medical Research Future Fund, Queensland Health, Canadian Institutes of Health Research (CIHR)
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incremental HD | Experimental | Other: Incremental HDParticipants 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. |
| Conventional HD | Other | Other: Conventional HDParticipants randomised to conventional HD will commence HD thrice weekly from the first HD session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥ 18 years of age) and
- Commencing HD as their initial dialysis therapy and
- Able to give informed consent
Key exclusion criteria (2 listed)
- Urine output <0.5Litres/day
- Unlikely to be on HD for ≥1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incremental HDStarting haemodialysis at twice weekly frequency | Other | Incremental HD |
| Conventional HDStarting haemodialysis at thrice weekly frequency | Other | Conventional HD |
Primary outcome
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.
16 secondary outcomes
Residual kidney function (RKF)
Time frame: Baseline, 3, 6, 12 and 18 months
Healthcare resource utilisation
Time frame: Baseline to 18 months
Healthcare costs
Time frame: 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 using EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire
Time frame: Baseline, monthly to 18 months
Incidence of all-cause mortality
Time frame: Baseline to 18 months
Time to major cardiovascular event (MACE)
Time frame: Baseline to 18 months
Number of non-elective hospital admissions
Time frame: Baseline to 18 months
Total hospital days
Time frame: Baseline to 18 months
Time to death
Time frame: Baseline to 18 months
Number of hospital admissions
Time frame: Baseline to 18 months
Adverse events and side-effects
Time frame: Baseline to 18 months
Symptom scores
Time frame: Baseline, 3, 6, 9, 12, 15 and 18 months
Fatigue
Time frame: Baseline, 3, 6, 9, 12, 15 and 18 months
Nutritional Status
Time frame: Baseline, 6, 12 and 18 months
Vascular access
Time frame: Baseline to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Kerr, Prof principal investigator
University of Queensland, Monash University
David Johnson, Prof principal investigator
University of Queensland, Queensland Health
Andrea Viecelli, Dr principal investigator
University of Queensland, Queensland Health
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incremental HD and Conventional HD in people with Kidney Failure, run by The University of Queensland at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisan Mulvey (+61 417 690 237, inch-hd.trial@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heath related quality of life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.