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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06642597




Registration number
NCT06642597
Ethics application status
Date submitted
10/10/2024
Date registered
15/10/2024

Titles & IDs
Public title
STarting incrEmental Prescription of Peritoneal Dialysis
Scientific title
An International, Multi-centre, Randomised Controlled Trial Co-designed With Consumers With Lived Experience of Peritoneal Dialysis (PD) to Determine the Optimal Approach to Starting Patients With Kidney Failure on PD
Secondary ID [1] 0 0
AKTN 24.01
Universal Trial Number (UTN)
Trial acronym
STEP-PD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneal Dialysis (PD) 0 0
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 PD
Other interventions - Full dose PD

Experimental: Incremental PD - Incremental PD: Commence PD using goal-directed PD prescription =14 exchanges/week for continuous ambulatory PD (CAPD) or =21 exchanges/week for automated PD (APD) with no day dwell until an indication for increase in the PD dose (trigger point) is reached.

Active comparator: Full dose PD - Full dose PD: Commence with 24 hours, 7 days/week PD (i.e., CAPD =28 exchanges/week or APD (overnight) with day dwell (i.e., no dry abdomen)).


Other interventions: Incremental PD
Incremental PD: Commence PD using goal-directed PD prescription =14 exchanges/week for continuous ambulatory PD (CAPD) or =21 exchanges/week for automated PD (APD) with no day dwell until an indication for increase in the PD dose (trigger point) is reached.

Other interventions: Full dose PD
Full dose PD: Commence with 24 hours, 7 days/week PD (i.e., CAPD =28 exchanges/week or APD (overnight) with day dwell (i.e., no dry abdomen)).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Quality of Life (QoL)
Timepoint [1] 0 0
From enrollment to the end of treatment at 6 months
Secondary outcome [1] 0 0
Residual Kidney Function (RKF)
Timepoint [1] 0 0
From enrollment to 3, 6, 9, 12 and 18 months
Secondary outcome [2] 0 0
Anuria
Timepoint [2] 0 0
From enrollment to 3, 6, 9, 12 and 18 months
Secondary outcome [3] 0 0
Serious adverse event
Timepoint [3] 0 0
Enrollment to 18 months
Secondary outcome [4] 0 0
Death
Timepoint [4] 0 0
Enrollment to 18 months
Secondary outcome [5] 0 0
Major cardiovascular event
Timepoint [5] 0 0
Enrollment to 18 months
Secondary outcome [6] 0 0
Peritonitis
Timepoint [6] 0 0
Enrollment to 18 months
Secondary outcome [7] 0 0
Non-elective hospitalisations
Timepoint [7] 0 0
Enrollment to 18 months
Secondary outcome [8] 0 0
Hospitalisations
Timepoint [8] 0 0
Enrollment to 18 months
Secondary outcome [9] 0 0
Quality of Life (QOL) and life participation
Timepoint [9] 0 0
Enrollment to 18 months

Eligibility
Key inclusion criteria
* adults (=18 years) commencing PD as their first dialysis therapy (and been on dialysis for <1 month)
* 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
* urine output <0.5L/day
* previous kidney transplant
* unlikely to be on dialysis for =1 year.
* known or planned pregnancy during the trial

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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2029
Actual
Sample size
Target
224
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4102 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Associate Professor Yeoungjee Cho
Address 0 0
Country 0 0
Phone 0 0
+61 7 3176 5080
Fax 0 0
Email 0 0
yeoungjee.cho@health.qld.gov.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data sets will be made available to researchers within STEP-PD for analysis of sub-studies and country-specific outcomes after the primary manuscript has been accepted for publication.

For researchers outside STEP-PD, individual participant data will be made available upon request to a Data Access Committee, a review board set up to assess proposals based on sound science, benefit-risk balancing, and research team expertise. Ethics approval will be required. This process will be in effect for a period of 2 to 5 years following publication of the main study results.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
When will data be available (start and end dates)?
A period of 2 to 5 years following publication of the main study results.
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06642597