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

Kidney Failure Clinical Trial

Official title:

The INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD) Study: a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932148
• Other study ID #: AKTN 20.04
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2022
• Est. completion date: August 2026

Study information

• Verified date: March 2024
• Source: The University of Queensland
• Contact: Ruth Stastny
• Phone: +61 417 690 237
• Email: inch-hd.trial[@]uq.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 372
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Other:
• Incremental HD
Starting haemodialysis at twice weekly frequency
• Conventional HD
Starting haemodialysis at thrice weekly frequency

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Bundaberg Hospital	Bundaberg	Queensland
Australia	Cairns Hospital	Cairns	Queensland
Australia	Redland Hospital	Cleveland	Queensland
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Northern Beaches Hospital	Frenchs Forest	New South Wales
Australia	St George Hospital	Kogarah	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Logan Hospital	Logan	Queensland
Australia	Eastern Health	Melbourne	Victoria
Australia	Monash Health	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	John Hunter Hospital	New Lambton Heights	New South Wales
Australia	Royal North Shore Hospital	Saint Leonards	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Canada	University Health Network- University of Toronto	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
The University of Queensland	Canadian Institutes of Health Research (CIHR), Medical Research Future Fund, Queensland Health

Countries where clinical trial is conducted

Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient lifestyle and wellbeing	This will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) SF 4a (Ability to Participate in Social Roles and Activities and Satisfaction with Social Roles and Activities)	Baseline, 3, 6, 9, 12, 15 and 18 months
Other	Time to event	Time to trigger condition being met in Incremental HD patients (date the trigger condition/s were met) and subsequent time to transition to 3x/week HD	Baseline to 18 months
Primary	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.	6 months
Secondary	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.	Baseline, 3, 6, 12 and 18 months
Secondary	Healthcare resource utilisation	Healthcare resource use over 18 months using linked data and patient monthly calendars	Baseline to 18 months
Secondary	Healthcare costs	Healthcare costs over 18 months using linked data and patient monthly calendars	Baseline to 18 months
Secondary	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.	Baseline, 3, 6, 9, 12, 15 and 18 months
Secondary	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.	Baseline, monthly to 18 months
Secondary	Incidence of all-cause mortality	Incidence of all-cause mortality up to 18 months	Baseline to 18 months
Secondary	Time to major cardiovascular event (MACE)	Time to first major cardiovascular event (MACE) up to 18 months	Baseline to 18 months
Secondary	Number of non-elective hospital admissions	Number of non-elective hospital admissions up to 18 months	Baseline to 18 months
Secondary	Total hospital days	Total hospital days up to 18 months	Baseline to 18 months
Secondary	Time to death	Time to death up to 18 months	Baseline to 18 months
Secondary	Number of hospital admissions	Number of hospital admissions up to 18 months	Baseline to 18 months
Secondary	Adverse events and side-effects	This will include episodes of hyperkalaemia, extra dialysis sessions for fluid overload, number of vascular access complications	Baseline to 18 months
Secondary	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.	Baseline, 3, 6, 9, 12, 15 and 18 months
Secondary	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).	Baseline, 3, 6, 9, 12, 15 and 18 months
Secondary	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)	Baseline, 6, 12 and 18 months
Secondary	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	Baseline to 18 months