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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Scientific title
The INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD) Study: a Randomised Controlled Trial
Secondary ID [1] 0 0
AKTN 20.04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Heath related quality of life
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Residual kidney function (RKF)
Timepoint [1] 0 0
Baseline, 3, 6, 12 and 18 months
Secondary outcome [2] 0 0
Healthcare resource utilisation
Timepoint [2] 0 0
Baseline to 18 months
Secondary outcome [3] 0 0
Healthcare costs
Timepoint [3] 0 0
Baseline to 18 months
Secondary outcome [4] 0 0
Heath related quality of life using Kidney Disease Quality of Life Short Form (KSQOL-SF) questionnaire
Timepoint [4] 0 0
Baseline, 3, 6, 9, 12, 15 and 18 months
Secondary outcome [5] 0 0
Heath related quality of life using EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire
Timepoint [5] 0 0
Baseline, monthly to 18 months
Secondary outcome [6] 0 0
Incidence of all-cause mortality
Timepoint [6] 0 0
Baseline to 18 months
Secondary outcome [7] 0 0
Time to major cardiovascular event (MACE)
Timepoint [7] 0 0
Baseline to 18 months
Secondary outcome [8] 0 0
Number of non-elective hospital admissions
Timepoint [8] 0 0
Baseline to 18 months
Secondary outcome [9] 0 0
Total hospital days
Timepoint [9] 0 0
Baseline to 18 months
Secondary outcome [10] 0 0
Time to death
Timepoint [10] 0 0
Baseline to 18 months
Secondary outcome [11] 0 0
Number of hospital admissions
Timepoint [11] 0 0
Baseline to 18 months
Secondary outcome [12] 0 0
Adverse events and side-effects
Timepoint [12] 0 0
Baseline to 18 months
Secondary outcome [13] 0 0
Symptom scores
Timepoint [13] 0 0
Baseline, 3, 6, 9, 12, 15 and 18 months
Secondary outcome [14] 0 0
Fatigue
Timepoint [14] 0 0
Baseline, 3, 6, 9, 12, 15 and 18 months
Secondary outcome [15] 0 0
Nutritional Status
Timepoint [15] 0 0
Baseline, 6, 12 and 18 months
Secondary outcome [16] 0 0
Vascular access
Timepoint [16] 0 0
Baseline to 18 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Urine output <0.5Litres/day
2. Unlikely to be on HD for =1 year.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
372
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [6] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [7] 0 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [8] 0 0
Cairns Hospital - Cairns
Recruitment hospital [9] 0 0
Redland Hospital - Cleveland
Recruitment hospital [10] 0 0
Logan Hospital - Logan
Recruitment hospital [11] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [12] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [13] 0 0
Monash Health - Melbourne
Recruitment hospital [14] 0 0
Eastern Health - Melbourne
Recruitment hospital [15] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2086 - Frenchs Forest
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [6] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [7] 0 0
- Bundaberg
Recruitment postcode(s) [8] 0 0
- Cairns
Recruitment postcode(s) [9] 0 0
4163 - Cleveland
Recruitment postcode(s) [10] 0 0
4131 - Logan
Recruitment postcode(s) [11] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [12] 0 0
5000 - Adelaide
Recruitment postcode(s) [13] 0 0
3168 - Melbourne
Recruitment postcode(s) [14] 0 0
- Melbourne
Recruitment postcode(s) [15] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Medical Research Future Fund
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Queensland Health
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Canadian Institutes of Health Research (CIHR)
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04932148
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Kerr, Prof
Address 0 0
University of Queensland, Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ruth Stastny
Address 0 0
Country 0 0
Phone 0 0
+61 417 690 237
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04932148