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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
Date last updated
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)
Assessment method [1] 0 0
Symptom burden-related QOL 6 months after dialysis start, assessed by the Symptoms and Problems of Kidney Disease (SPKD) component of KDQOL-36 (0 to 100; worst to best).
Timepoint [1] 0 0
From enrollment to the end of treatment at 6 months
Secondary outcome [1] 0 0
Residual Kidney Function (RKF)
Assessment method [1] 0 0
Slope of RKF decline over time modelled with linear regression of the arithmetic means of 24-hour urinary urea and creatinine clearances at months 3, 6, 9, 12 and 18
Timepoint [1] 0 0
From enrollment to 3, 6, 9, 12 and 18 months
Secondary outcome [2] 0 0
Anuria
Assessment method [2] 0 0
Proportion of patients with anuria (\<100mL/24h) at months 3, 6, 9, 12 and 18
Timepoint [2] 0 0
From enrollment to 3, 6, 9, 12 and 18 months
Secondary outcome [3] 0 0
Serious adverse event
Assessment method [3] 0 0
Number of category type of serious adverse events
Timepoint [3] 0 0
Enrollment to 18 months
Secondary outcome [4] 0 0
Death
Assessment method [4] 0 0
Time to all-cause mortality
Timepoint [4] 0 0
Enrollment to 18 months
Secondary outcome [5] 0 0
Major cardiovascular event
Assessment method [5] 0 0
Time to first major cardiovascular event (defined as acute myocardial infarction)
Timepoint [5] 0 0
Enrollment to 18 months
Secondary outcome [6] 0 0
Peritonitis
Assessment method [6] 0 0
Time to first peritonitis event
Timepoint [6] 0 0
Enrollment to 18 months
Secondary outcome [7] 0 0
Non-elective hospitalisations
Assessment method [7] 0 0
Number of non-elective hospital admissions
Timepoint [7] 0 0
Enrollment to 18 months
Secondary outcome [8] 0 0
Hospitalisations
Assessment method [8] 0 0
Hospitalisation for fluid overload, hyperkalaemia, or uraemic complications; episodes of hyperkalaemia (=6mmol/L)
Timepoint [8] 0 0
Enrollment to 18 months
Secondary outcome [9] 0 0
Quality of Life (QOL) and life participation
Assessment method [9] 0 0
QOL and life participation: quarterly KDQOL-36 (physical and mental composite scores; effects and burden of kidney disease) and the SF6D (a component of the KDQOL)
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 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
Email 0 0
yeoungjee.cho@health.qld.gov.au
Contact person for scientific queries

Data sharing statement


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