RecruitingNot ApplicableNCT06642597

STarting incrEmental Prescription of Peritoneal Dialysis

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


Sponsor

The University of Queensland

Enrollment

224 participants

Start Date

Sep 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria4

  • urine output <0.5L/day
  • previous kidney transplant
  • unlikely to be on dialysis for ≥1 year.
  • known or planned pregnancy during the trial

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Interventions

OTHERIncremental 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.

OTHERFull 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)).


Locations(6)

Blacktown

Blacktown, New South Wales, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Eastern Health

Box Hill, Victoria, Australia

Hallym University Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Taichung Veterans General Hospital

Taichung, Xitun District, Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, Pathum Wan, Thailand

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NCT06642597


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