Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001654145
Ethics application status
Approved
Date submitted
24/10/2019
Date registered
26/11/2019
Date last updated
26/10/2022
Date data sharing statement initially provided
26/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison between five-days per week versus daily dialysis in patients starting peritoneal dialysis on clinical outcomes and quality of life
Scientific title
The effect of incremental peritoneal dialysis on clinical outcomes and quality of life in incident dialysis patients.
Secondary ID [1] 299641 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney failure 314960 0
Condition category
Condition code
Renal and Urogenital 313306 313306 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Incremental peritoneal dialysis, by performing five days a week of dialysis instead of daily, will be compared to daily peritoneal dialysis, in incident peritoneal dialysis patients. This type of dialysis is usually performed on a daily basis, by the patients in their own homes. There is a wide range of treatment duration (from 8 to 24 hours, depending on patient preference and their dialysis requirement, and usually lasts 3-5 years). Peritoneal dialysis can either be done manually (aided by gravity), or using an automated machine pump - both are the standard of care and are chosen by patients depending on their lifestyle. This study is not a comparison between manual vs automated techniques; rather, it aims to compare 5 days versus daily dialysis.

Adherence of incremental or daily peritoneal dialysis will be reviewed during three monthly clinic visits, telephone reviews, as well as assessing remote monitoring data built in to dialysis machines (in participating units).
Intervention code [1] 315901 0
Treatment: Other
Comparator / control treatment
The control group is formed by patients on daily peritoneal dialysis - the current standard of care. Specifically, peritoneal dialysis will be done 7 days a week, by the patients, in their own homes. The treatment duration is again variable, ranging from 8-24 hours, depending on patient preference and their dialysis requirement, for up to 3-5 years. Either manual or automated peritoneal dialysis will be performed by this group, as determined by patient preference.
Control group
Active

Outcomes
Primary outcome [1] 321785 0
Duration of incremental peritoneal dialysis until requiring daily dialysis (when kidney creatinine clearance < 50 L/week/1.73m^2) as determined by 24 hour urine collection, or if participants display evidence of inadequate dialysis clinically, or on blood tests for urea and creatinine)
Timepoint [1] 321785 0
Every 3 months from study entry for 12 months for the 24 hour urine collections.
Clinical review by a doctor every 3 months.
Blood tests every month.
Secondary outcome [1] 376195 0
Quality of life score (KDQOL SF 1.3)
Timepoint [1] 376195 0
At baseline, 6 and 12 months post randomisation
Secondary outcome [2] 376196 0
Residual kidney creatinine clearance (L/week/1.73m^2) on 24 hour urine collection.
Timepoint [2] 376196 0
Every 3 months from study entry for 12 months for the 24 hour urine collections.
Secondary outcome [3] 376197 0
Peritoneal membrane D/P creatinine on PET/Adequest test (a test that compares the change of creatinine concentration in the spent dialysate at time 0, 1 and 4 hours after infusion into the abdomen).
Timepoint [3] 376197 0
At 6 weeks after starting study and at 1 year
Secondary outcome [4] 376198 0
Safety (composite outcome of hospital admissions for fluid overload (determined clinically by physical examination) and hyperkalaemia (measuring potassium on a blood test).
Hospital admissions will be determined by a number of ways, including patient reporting, automated alert from electronic medical record programme to the trial doctor and trial coordinator, or retrospective review of electronic medical records.
Timepoint [4] 376198 0
Assessed every 3 months for 12 months.
Secondary outcome [5] 376199 0
Peritonitis episodes, reported as episodes per year. Peritonitis is defined as a peritoneal dialysate polymorphonuclear cell count >100 million/L (dialysate microscopy), with evidence of cloudy fluid or abdominal pain (patient medical records).
Peritonitis episodes will be tracked by the home dialysis unit of the hospital and reported to the study doctor and study coordinator, or be retrospectively reviewed on eletronic medical records.
Timepoint [5] 376199 0
At 1 year post randomisation

Eligibility
Key inclusion criteria
Able to provide informed consent.
Residual kidney creatinine clearance >50 L/week/1.73m^2 on 24 hour urine collection.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Been on haemodialysis or peritoneal dialysis for >3 months.
Life expectancy <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)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table created by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomised 1:1 (incremental : control)
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this study is a pilot, the primary outcome of "duration of incremental peritoneal dialysis" until needing daily dialysis does not allow power calculation. This result will be reported using descriptive statistics.

The secondary end points will allow comparison between the incremental vs. control groups, using mixed linear models to compare rate of decline of residual kidney function, Kaplan Meier statistics to compare time to first peritonitis, and ANOVA with repeat measures for mean quality of life scores.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2020
Actual
8/10/2020
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
40
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15041 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 16753 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 16754 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 28328 0
3128 - Box Hill
Recruitment postcode(s) [2] 30374 0
3084 - Heidelberg
Recruitment postcode(s) [3] 30375 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 304115 0
Hospital
Name [1] 304115 0
Eastern Health Integrated Renal Service
Country [1] 304115 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
5 Arnold Street
Box Hill VIC 3128
Country
Australia
Secondary sponsor category [1] 304330 0
None
Name [1] 304330 0
Address [1] 304330 0
Country [1] 304330 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304602 0
Monash Health HREC
Ethics committee address [1] 304602 0
Ethics committee country [1] 304602 0
Australia
Date submitted for ethics approval [1] 304602 0
20/01/2020
Approval date [1] 304602 0
31/03/2020
Ethics approval number [1] 304602 0
RES-20-0000-101A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97542 0
Dr Louis Huang
Address 97542 0
Eastern Health
Department of Renal Medicine
Level 2, 5 Arnold Street
Box Hill VIC 3128
Country 97542 0
Australia
Phone 97542 0
+61 3 98953333
Fax 97542 0
Email 97542 0
[email protected]
Contact person for public queries
Name 97543 0
Louis Huang
Address 97543 0
Eastern Health
Department of Renal Medicine
Level 2, 5 Arnold Street
Box Hill VIC 3128
Country 97543 0
Australia
Phone 97543 0
+61 3 98953333
Fax 97543 0
Email 97543 0
[email protected]
Contact person for scientific queries
Name 97544 0
Louis Huang
Address 97544 0
Eastern Health
Department of Renal Medicine
Level 2, 5 Arnold Street
Box Hill VIC 3128
Country 97544 0
Australia
Phone 97544 0
+61 3 98953333
Fax 97544 0
Email 97544 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.