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

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.

• Residual kidney function (RKF) [Срок оценки: Baseline, 3, 6, 12 and 18 months]
• Healthcare resource utilisation [Срок оценки: Baseline to 18 months]
• Healthcare costs [Срок оценки: Baseline to 18 months]
• Heath related quality of life using Kidney Disease Quality of Life Short Form (KSQOL-SF) questionnaire [Срок оценки: Baseline, 3, 6, 9, 12, 15 and 18 months]
• Heath related quality of life using EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire [Срок оценки: Baseline, monthly to 18 months]
• Incidence of all-cause mortality [Срок оценки: Baseline to 18 months]
• Time to major cardiovascular event (MACE) [Срок оценки: Baseline to 18 months]
• Number of non-elective hospital admissions [Срок оценки: Baseline to 18 months]
• Total hospital days [Срок оценки: Baseline to 18 months]
• Time to death [Срок оценки: Baseline to 18 months]
• Number of hospital admissions [Срок оценки: Baseline to 18 months]
• Adverse events and side-effects [Срок оценки: Baseline to 18 months]