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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Failure

Intervention / Treatment
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* Other: Incremental HD
* Other: Conventional HD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Incremental HD<br>Participants randomised to incremental HD will commence HD twice weekly and continue until an indication for an increase to three sessions/week (trigger point) is reached. | Other: Incremental HD<br>* Starting haemodialysis at twice weekly frequency<br>|
| Other: Conventional HD<br>Participants randomised to conventional HD will commence HD thrice weekly from the first HD session. | Other: Conventional HD<br>* Starting haemodialysis at thrice weekly frequency<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Healthcare resource utilisation | Healthcare resource use over 18 months using linked data and patient monthly calendars | Baseline to 18 months | 
| Healthcare costs | Healthcare costs over 18 months using linked data and patient monthly calendars | Baseline to 18 months | 
| 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 | 
| 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 | 
| Incidence of all-cause mortality | Incidence of all-cause mortality up to 18 months | Baseline to 18 months | 
| Time to major cardiovascular event (MACE) | Time to first major cardiovascular event (MACE) up to 18 months | Baseline to 18 months | 
| Number of non-elective hospital admissions | Number of non-elective hospital admissions up to 18 months | Baseline to 18 months | 
| Total hospital days | Total hospital days up to 18 months | Baseline to 18 months | 
| Time to death | Time to death up to 18 months | Baseline to 18 months | 
| Number of hospital admissions | Number of hospital admissions up to 18 months | Baseline to 18 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incident HD, Incremental HD