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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04932148
Registration number
NCT04932148
Ethics application status
Date submitted
8/06/2021
Date registered
18/06/2021
Date last updated
18/04/2024
Titles & IDs
Public title
INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)
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Scientific title
The INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD) Study: a Randomised Controlled Trial
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Secondary ID [1]
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AKTN 20.04
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Kidney Failure
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Incremental HD
Other interventions - Conventional HD
Experimental: Incremental HD - 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: Conventional HD - Participants randomised to conventional HD will commence HD thrice weekly from the first HD session.
Other interventions: Incremental HD
Starting haemodialysis at twice weekly frequency
Other interventions: Conventional HD
Starting haemodialysis at thrice weekly frequency
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Heath related quality of life
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Assessment method [1]
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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.
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Residual kidney function (RKF)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, 3, 6, 12 and 18 months
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Secondary outcome [2]
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Healthcare resource utilisation
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Assessment method [2]
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Healthcare resource use over 18 months using linked data and patient monthly calendars
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Timepoint [2]
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Baseline to 18 months
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Secondary outcome [3]
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Healthcare costs
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Assessment method [3]
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Healthcare costs over 18 months using linked data and patient monthly calendars
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Timepoint [3]
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Baseline to 18 months
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Secondary outcome [4]
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Heath related quality of life using Kidney Disease Quality of Life Short Form (KSQOL-SF) questionnaire
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, 3, 6, 9, 12, 15 and 18 months
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Secondary outcome [5]
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Heath related quality of life using EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, monthly to 18 months
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Secondary outcome [6]
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Incidence of all-cause mortality
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Assessment method [6]
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Incidence of all-cause mortality up to 18 months
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Timepoint [6]
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Baseline to 18 months
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Secondary outcome [7]
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Time to major cardiovascular event (MACE)
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Assessment method [7]
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Time to first major cardiovascular event (MACE) up to 18 months
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Timepoint [7]
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Baseline to 18 months
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Secondary outcome [8]
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Number of non-elective hospital admissions
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Assessment method [8]
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Number of non-elective hospital admissions up to 18 months
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Timepoint [8]
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Baseline to 18 months
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Secondary outcome [9]
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Total hospital days
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Assessment method [9]
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Total hospital days up to 18 months
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Timepoint [9]
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Baseline to 18 months
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Secondary outcome [10]
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Time to death
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Assessment method [10]
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Time to death up to 18 months
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Timepoint [10]
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Baseline to 18 months
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Secondary outcome [11]
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Number of hospital admissions
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Assessment method [11]
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Number of hospital admissions up to 18 months
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Timepoint [11]
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Baseline to 18 months
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Secondary outcome [12]
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Adverse events and side-effects
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Assessment method [12]
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This will include episodes of hyperkalaemia, extra dialysis sessions for fluid overload, number of vascular access complications
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Timepoint [12]
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Baseline to 18 months
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Secondary outcome [13]
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Symptom scores
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, 3, 6, 9, 12, 15 and 18 months
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Secondary outcome [14]
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Fatigue
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Assessment method [14]
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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).
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Timepoint [14]
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Baseline, 3, 6, 9, 12, 15 and 18 months
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Secondary outcome [15]
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Nutritional Status
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Assessment method [15]
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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)
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Timepoint [15]
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Baseline, 6, 12 and 18 months
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Secondary outcome [16]
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Vascular access
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Assessment method [16]
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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
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Timepoint [16]
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Baseline to 18 months
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Eligibility
Key inclusion criteria
1. Adults (= 18 years of age) and
2. Commencing HD as their initial dialysis therapy and
3. Able to give informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Urine output <0.5Litres/day
2. Unlikely to be on HD for =1 year.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/07/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2026
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Actual
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Sample size
Target
372
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Northern Beaches Hospital - Frenchs Forest
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Recruitment hospital [3]
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St George Hospital - Kogarah
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Recruitment hospital [4]
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Liverpool Hospital - Liverpool
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Recruitment hospital [5]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [6]
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Royal North Shore Hospital - Saint Leonards
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Recruitment hospital [7]
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Bundaberg Hospital - Bundaberg
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Recruitment hospital [8]
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Cairns Hospital - Cairns
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Recruitment hospital [9]
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Redland Hospital - Cleveland
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Recruitment hospital [10]
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Logan Hospital - Logan
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Recruitment hospital [11]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [12]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [13]
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Monash Health - Melbourne
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Recruitment hospital [14]
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Eastern Health - Melbourne
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Recruitment hospital [15]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2086 - Frenchs Forest
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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2305 - New Lambton Heights
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Recruitment postcode(s) [6]
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2065 - Saint Leonards
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Recruitment postcode(s) [7]
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- Bundaberg
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Recruitment postcode(s) [8]
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- Cairns
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Recruitment postcode(s) [9]
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4163 - Cleveland
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Recruitment postcode(s) [10]
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4131 - Logan
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Recruitment postcode(s) [11]
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4102 - Woolloongabba
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Recruitment postcode(s) [12]
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5000 - Adelaide
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Recruitment postcode(s) [13]
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3168 - Melbourne
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Recruitment postcode(s) [14]
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- Melbourne
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Recruitment postcode(s) [15]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Medical Research Future Fund
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Queensland Health
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Canadian Institutes of Health Research (CIHR)
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04932148
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Peter Kerr, Prof
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Address
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University of Queensland, Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ruth Stastny
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Address
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Country
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Phone
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+61 417 690 237
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04932148
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