INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Incremental HD, Conventional HD.
- Who it may be relevant to
- Registry conditions: Kidney Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD) Study: a Randomised Controlled Trial
Overview
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.
Interventions
- Other Incremental HD
Starting haemodialysis at twice weekly frequency - Other Conventional HD
Starting haemodialysis at thrice weekly frequency
Primary outcome measures
- Heath related quality of life [Time frame: 6 months]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- Adults (≥ 18 years of age) and
- Commencing HD as their initial dialysis therapy and
- Able to give informed consent
Exclusion criteria
- Urine output <0.5Litres/day
- Unlikely to be on HD for ≥1 year.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Australia · 17 centers
- Concord Repatriation General Hospital — Concord
- Northern Beaches Hospital — Frenchs Forest
- St George Hospital — Kogarah
- Liverpool Hospital — Liverpool
- John Hunter Hospital — New Lambton Heights
- Port Macquarie Hospital — Port Macquarie
- Royal North Shore Hospital — Saint Leonards
- Bundaberg Hospital — Bundaberg
- … and 9 more centers
Canada · 1 center
- University Health Network- University of Toronto — Toronto
Identifiers
NCT: NCT04932148 · AKTN 20.04