INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)
ConditionKidney Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Queensland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥ 18 years of age) and
Commencing HD as their initial dialysis therapy and
Able to give informed consent
Disqualifiers
Urine output <0.5Litres/day
Unlikely to be on HD for ≥1 year.
Trial design
Design model
Parallel
Treatments tested in this trial
Incremental HD
Other interventionStarting haemodialysis at twice weekly frequency
Conventional HD
Other interventionStarting haemodialysis at thrice weekly frequency
Treatment groups
372 Participants
are divided into 2 treatment groupsGroup A: Incremental HDExperimental treatment 1 intervention
Group B: Conventional HDOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 monthsSecondary outcomes
1
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.
Time frame
Baseline, 3, 6, 12 and 18 months2
Healthcare resource utilisation
Healthcare resource use over 18 months using linked data and patient monthly calendars
Time frame
Baseline to 18 months3
Healthcare costs
Healthcare costs over 18 months using linked data and patient monthly calendars
Time frame
Baseline to 18 months4
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.
Time frame
Baseline, 3, 6, 9, 12, 15 and 18 monthsOther outcomes
1
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)
Time frame
Baseline, 3, 6, 9, 12, 15 and 18 months2
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
Time frame
Baseline to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Queensland
Lead sponsor
Medical Research Future Fund
Collaborator
Queensland Health
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov