STarting incrEmental Prescription of Peritoneal Dialysis
STEP-PD
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
1 other identifier
interventional
224
4 countries
6
Brief Summary
Kidney failure is fatal without dialysis. Peritoneal dialysis (PD) completed at home offers greater flexibility and autonomy for patients . However, PD is often prescribed for 24 hours/day, 7 days/week for every patient starting dialysis. This practice is not evidence-informed, may be unnecessary and potentially harmful. The STEP-PD trial aims to determine the optimal approach to commencing patients on PD through starting at low dose PD and incrementing over time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedStudy Start
First participant enrolled
September 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2029
March 19, 2026
January 1, 2026
4 years
October 10, 2024
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life (QoL)
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).
From enrollment to the end of treatment at 6 months
Secondary Outcomes (9)
Residual Kidney Function (RKF)
From enrollment to 3, 6, 9, 12 and 18 months
Anuria
From enrollment to 3, 6, 9, 12 and 18 months
Serious adverse event
Enrollment to 18 months
Death
Enrollment to 18 months
Major cardiovascular event
Enrollment to 18 months
- +4 more secondary outcomes
Study Arms (2)
Incremental PD
EXPERIMENTALIncremental 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.
Full dose PD
ACTIVE COMPARATORFull 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)).
Interventions
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.
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)).
Eligibility Criteria
You may qualify if:
- adults (≥18 years) commencing PD as their first dialysis therapy (and been on dialysis for \<1 month)
- able to give informed consent
You may not qualify if:
- urine output \<0.5L/day
- previous kidney transplant
- unlikely to be on dialysis for ≥1 year.
- known or planned pregnancy during the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Blacktown
Blacktown, New South Wales, 2148, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Eastern Health
Box Hill, Victoria, 3218, Australia
Hallym University Sacred Heart Hospital
Chuncheon, Gangwon-do, 14068, South Korea
Taichung Veterans General Hospital
Taichung, Xitun District, 1650, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, Pathum Wan, 10330, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2024
First Posted
October 15, 2024
Study Start
September 19, 2025
Primary Completion (Estimated)
September 30, 2029
Study Completion (Estimated)
September 30, 2029
Last Updated
March 19, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- A period of 2 to 5 years following publication of the main study results.
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.