Clinical trial NCT04932148: INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)
Official title: The INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD) Study: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Failure
Keywords: Incremental HD
Incident HD
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Medical Research Future Fund
name: Queensland Health
name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-06-18
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Heath related quality of life
timeFrame: 6 months
Secondary outcomes:
measure: Residual kidney function (RKF)
timeFrame: Baseline, 3, 6, 12 and 18 months
measure: Healthcare resource utilisation
timeFrame: Baseline to 18 months
measure: Healthcare costs
timeFrame: Baseline to 18 months
measure: Heath related quality of life using Kidney Disease Quality of Life Short Form (KSQOL-SF) questionnaire
timeFrame: Baseline, 3, 6, 9, 12, 15 and 18 months
measure: Heath related quality of life using EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire
timeFrame: Baseline, monthly to 18 months
measure: Incidence of all-cause mortality
timeFrame: Baseline to 18 months
measure: Time to major cardiovascular event (MACE)
timeFrame: Baseline to 18 months
measure: Number of non-elective hospital admissions
timeFrame: Baseline to 18 months
measure: Total hospital days
timeFrame: Baseline to 18 months
measure: Time to death
timeFrame: Baseline to 18 months
measure: Number of hospital admissions
timeFrame: Baseline to 18 months
measure: Adverse events and side-effects
timeFrame: Baseline to 18 months
measure: Symptom scores
timeFrame: Baseline, 3, 6, 9, 12, 15 and 18 months
measure: Fatigue
timeFrame: Baseline, 3, 6, 9, 12, 15 and 18 months
measure: Nutritional Status
timeFrame: Baseline, 6, 12 and 18 months
measure: Vascular access
timeFrame: Baseline to 18 months
Other outcomes:
measure: Patient lifestyle and wellbeing
timeFrame: Baseline, 3, 6, 9, 12, 15 and 18 months
measure: Time to event
timeFrame: Baseline to 18 months
Locations:
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Frenchs Forest
country: Australia
facility: Northern Beaches Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Bundaberg
country: Australia
facility: Bundaberg Hospital
state: Queensland
city: Cairns
country: Australia
facility: Cairns Hospital
state: Queensland
city: Cleveland
country: Australia
facility: Redland Hospital
state: Queensland
city: Logan
country: Australia
facility: Logan Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Monash Health
state: Victoria
city: Melbourne
country: Australia
facility: Eastern Health
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Toronto
country: Canada
facility: University Health Network- University of Toronto
state: Ontario
Study officials:
affiliation: University of Queensland, Monash University
name: Peter Kerr, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Queensland, Queensland Health
name: David Johnson, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Queensland, Queensland Health
name: Andrea Viecelli, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Charmaine Lok, Prof
role: PRINCIPAL_INVESTIGATOR
References: