INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)
Primary Purpose
Kidney Failure
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Incremental HD
Conventional HD
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure focused on measuring Incremental HD, Incident HD
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.
Sites / Locations
- Redland Hospital
- Logan HospitalRecruiting
- Princess Alexandra HospitalRecruiting
- University Health Network- University of Toronto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Incremental HD
Conventional HD
Arm Description
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.
Participants randomised to conventional HD will commence HD thrice weekly from the first HD session.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Healthcare resource utilisation
Healthcare resource use over 18 months using linked data and patient monthly calendars
Healthcare costs
Healthcare costs over 18 months using linked data and patient monthly calendars
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.
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.
Incidence of all-cause mortality
Incidence of all-cause mortality up to 18 months
Time to major cardiovascular event (MACE)
Time to first major cardiovascular event (MACE) up to 18 months
Number of non-elective hospital admissions
Number of non-elective hospital admissions up to 18 months
Total hospital days
Total hospital days up to 18 months
Time to death
Time to death up to 18 months
Number of hospital admissions
Number of hospital admissions up 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
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.
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).
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)
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
Full Information
NCT ID
NCT04932148
First Posted
June 8, 2021
Last Updated
April 20, 2023
Sponsor
The University of Queensland
Collaborators
Medical Research Future Fund, Queensland Health, Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT04932148
Brief Title
INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)
Official Title
The INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD) Study: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Queensland
Collaborators
Medical Research Future Fund, Queensland Health, Canadian Institutes of Health Research (CIHR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
Keywords
Incremental HD, Incident HD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
372 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Incremental HD
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional HD
Arm Type
Other
Arm Description
Participants randomised to conventional HD will commence HD thrice weekly from the first HD session.
Intervention Type
Other
Intervention Name(s)
Incremental HD
Intervention Description
Starting haemodialysis at twice weekly frequency
Intervention Type
Other
Intervention Name(s)
Conventional HD
Intervention Description
Starting haemodialysis at thrice weekly frequency
Primary Outcome Measure Information:
Title
Heath related quality of life
Description
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 months
Secondary Outcome Measure Information:
Title
Residual kidney function (RKF)
Description
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 months
Title
Healthcare resource utilisation
Description
Healthcare resource use over 18 months using linked data and patient monthly calendars
Time Frame
Baseline to 18 months
Title
Healthcare costs
Description
Healthcare costs over 18 months using linked data and patient monthly calendars
Time Frame
Baseline to 18 months
Title
Heath related quality of life using Kidney Disease Quality of Life Short Form (KSQOL-SF) questionnaire
Description
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 months
Title
Heath related quality of life using EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire
Description
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.
Time Frame
Baseline, monthly to 18 months
Title
Incidence of all-cause mortality
Description
Incidence of all-cause mortality up to 18 months
Time Frame
Baseline to 18 months
Title
Time to major cardiovascular event (MACE)
Description
Time to first major cardiovascular event (MACE) up to 18 months
Time Frame
Baseline to 18 months
Title
Number of non-elective hospital admissions
Description
Number of non-elective hospital admissions up to 18 months
Time Frame
Baseline to 18 months
Title
Total hospital days
Description
Total hospital days up to 18 months
Time Frame
Baseline to 18 months
Title
Time to death
Description
Time to death up to 18 months
Time Frame
Baseline to 18 months
Title
Number of hospital admissions
Description
Number of hospital admissions up to 18 months
Time Frame
Baseline to 18 months
Title
Adverse events and side-effects
Description
This will include episodes of hyperkalaemia, extra dialysis sessions for fluid overload, number of vascular access complications
Time Frame
Baseline to 18 months
Title
Symptom scores
Description
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.
Time Frame
Baseline, 3, 6, 9, 12, 15 and 18 months
Title
Fatigue
Description
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).
Time Frame
Baseline, 3, 6, 9, 12, 15 and 18 months
Title
Nutritional Status
Description
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)
Time Frame
Baseline, 6, 12 and 18 months
Title
Vascular access
Description
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
Time Frame
Baseline to 18 months
Other Pre-specified Outcome Measures:
Title
Patient lifestyle and wellbeing
Description
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 months
Title
Time to event
Description
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 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aparna Shenoy, Dr
Phone
+61 417 327 331
Email
inch-hd.trial@uq.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Kerr, Prof
Organizational Affiliation
University of Queensland, Monash University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Wolley, Dr
Organizational Affiliation
University of Queensland, Queensland Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Viecelli, Dr
Organizational Affiliation
University of Queensland, Queensland Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charmaine Lok, Prof
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Redland Hospital
City
Cleveland
State/Province
Queensland
ZIP/Postal Code
4163
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Mudge, Dr
Facility Name
Logan Hospital
City
Logan
State/Province
Queensland
ZIP/Postal Code
4131
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinod Khelgi, Dr
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Viecelli, Dr
Email
Andrea.Viecelli@health.qld.gov.au
Facility Name
University Health Network- University of Toronto
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charmaine Lok
Email
charmaine.lok@uhn.ca
12. IPD Sharing Statement
Learn more about this trial
INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)
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