The INCremental dialysis to improve Health outcomes in people starting Haemodialysis (INCH-HD) study: a randomised controlled trial
Principal Investigators: Professor Peter Kerr and Dr Martin Wolley
Clinical Project Manager: Dr Alistair Mallard
Clinical Research Associate: Dr Aparna Shenoy
Trial Number: AKTN 20.04
Population: Adults aged over 18 years commencing haemodialysis (HD) as their initial dialysis therapy
Intervention: Incremental HD (twice weekly HD) versus Conventional HD (thrice weekly HD)
Follow-up: 18 months
Primary outcome: The kidney-specific component of KDQOL-SF from dialysis commencement as measured using KDQOL-SF v1.3
Status: Recruitment to commence Q4 2021
Target Recruitment: 372 participants from Australia, New Zealand, and Canada
Haemodialysis (HD) is the most common treatment for kidney failure globally, but it is associated with poor survival (<50% 5-year survival), high symptom burden, and the poorest quality of life (QOL) of any chronic disease. Quality of life is significantly reduced in patients receiving HD. Patients consistently identify dialysis-free time, ability to work, and fatigue as outcomes of critical importance, yet these outcomes are rarely addressed in clinical research.
INCH-HD is an adaptive, multi-centre, open label, randomised, non-inferiority trial looking at whether starting haemodialysis incrementally at two sessions/week compared to 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.
The primary outcome will be the kidney-specific component of KDQOL-SF questionnaire from dialysis commencement as measured using KDQOL-SF v1.3. Secondary outcomes include residual kidney function, healthcare resource utilisation and costs, quality of life, safety, adverse events and side effects, symptom and fatigue scores, nutritional status, and rate of vascular access interventions.
This study has received funding from Metro South Health Research Support Scheme Grant to cover the development phase.