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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Failure; Peritoneal Dialysis (PD)
• Intervention / Treatment: Other: Incremental PD; Other: Full dose PD

Detailed Description

The STEP-PD study is an investigator-initiated, pragmatic, international, multicentre, prospective, adaptive, randomised, open-label, parallel group, non-inferiority trial led by an international multi-disciplinary team of clinician scientists, nephrologists, consumers, social scientists, trialists, health economists, dialysis nurses, statisticians, and registry experts. The STEP-PD trial is co-designed with consumers with lived experience of peritoneal dialysis (PD) to determine the optimal approach to starting patients with kidney failure on PD. Specifically, this trial will test the hypothesis that, compared with full dose PD, starting patients on incremental start PD preserves symptom burden related quality of life (QOL), reduces dialysis burden, is safe, is more environmentally sustainable and costs less for patients, the community and the healthcare system. The STEP-PD trial has the potential to transform and personalise the treatment of kidney failure globally by providing definitive evidence on the patient-prioritised question regarding the effectiveness and safety of incremental start PD, particularly in relation to the patient-critical outcome of symptom burden-related QOL. Favourable results would lead to a paradigm shift in how patients are started on PD, thereby mitigating unnecessarily burdensome, expensive, and possibly harmful treatment.

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Hickey; Phone Number: +61 427 911 414; Email: step-pd@uq.edu.au
• Study Contact Backup: Name: Professor Yeoungjee Cho; Phone Number: +61 7 3176 5080; Email: yeoungjee.cho@health.qld.gov.au

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Recruiting
      • Blacktown
      • Contact: Katrina Chau, Associate Professor; Phone Number: +61 28670 8330; Email: Katrina.Chau@health.nsw.gov.au
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Not yet recruiting
      • Princess Alexandra Hospital
      • Contact: Yeoungjee Cho; Email: yeoungjee.cho@health.qld.gov.au
  • Victoria
    • Box Hill, Victoria, Australia, 3218
      • Recruiting
      • Eastern Health
      • Contact: Louis Huang; Phone Number: +610398957642; Email: louis.huang@monash.edu
• South Korea
  • Gangwon-do
    • Chuncheon, Gangwon-do, South Korea, 14068
      • Recruiting
      • Hallym University Sacred Heart Hospital
      • Contact: Jwa-Kyung Kim, Professor; Phone Number: 82-31-380-3720; Email: jwa816@naver.com
• Taiwan
  • Xitun District
    • Taichung, Xitun District, Taiwan, 1650
      • Recruiting
      • Taichung Veterans General Hospital
      • Contact: Mu Chi Chung, Associate Professor; Email: mcchung0322@gmail.com
• Thailand
  • Pathum Wan
    • Bangkok, Pathum Wan, Thailand, 10330
      • Recruiting
      • King Chulalongkorn Memorial Hospital
      • Contact: Talerngsak Kanjanabuch; Phone Number: 662-256-4251; Email: golfnephro@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adults (≥18 years) commencing PD as their first dialysis therapy (and been on dialysis for <1 month)
• able to give informed consent

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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: 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)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual Kidney Function (RKF)	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	From enrollment to 3, 6, 9, 12 and 18 months
Anuria	Proportion of patients with anuria (<100mL/24h) at months 3, 6, 9, 12 and 18	From enrollment to 3, 6, 9, 12 and 18 months
Serious adverse event	Number of category type of serious adverse events	Enrollment to 18 months
Death	Time to all-cause mortality	Enrollment to 18 months
Major cardiovascular event	Time to first major cardiovascular event (defined as acute myocardial infarction)	Enrollment to 18 months
Peritonitis	Time to first peritonitis event	Enrollment to 18 months
Non-elective hospitalisations	Number of non-elective hospital admissions	Enrollment to 18 months
Hospitalisations	Hospitalisation for fluid overload, hyperkalaemia, or uraemic complications; episodes of hyperkalaemia (≥6mmol/L)	Enrollment to 18 months
Quality of Life (QOL) and life participation	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)	Enrollment to 18 months

Collaborators and Investigators

• Sponsor: The University of Queensland

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 13, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: peritoneal dialysis; Kidney disease; Kidney failure; incremental start PD
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Kidney Diseases
• Other Study ID Numbers: AKTN 24.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: A period of 2 to 5 years following publication of the main study results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No