Starting peritoneal dialysis gradually with an incremental prescription
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
This trial will test whether beginning adults on peritoneal dialysis with a lower, gradually increased dose (incremental PD) works as well as starting full-dose PD for people who are just starting dialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Queensland Academic / other |
| Locations | 6 sites (Blacktown, New South Wales and 5 other locations) |
| Trial ID | NCT06642597 on ClinicalTrials.gov |
What this trial studies
STEP-PD is a pragmatic, international, multicentre, adaptive, randomized, open-label non-inferiority trial co-designed with patients and led by an interdisciplinary team. Adults starting peritoneal dialysis as their first dialysis treatment are randomized to either incremental PD (lower initial dose with planned increases) or conventional full-dose PD. The trial compares symptom-burden–related quality of life, safety, dialysis burden, environmental impact, and costs between the two approaches. The goal is to provide definitive evidence on whether incremental start PD can preserve quality of life while reducing burdens and costs.
Who should consider this trial
Good fit: Adults (≥18 years) who are commencing peritoneal dialysis as their first dialysis therapy, within about one month of starting dialysis, and who can give informed consent are ideal candidates.
Not a fit: Patients with very low or no urine output (<0.5 L/day), a prior kidney transplant, those unlikely to remain on dialysis for at least a year, or those who are pregnant are unlikely to benefit from the incremental approach tested here.
Why it matters
Potential benefit: If successful, incremental start PD could preserve symptom-related quality of life while reducing treatment burden, costs, and environmental impact for patients starting dialysis.
How similar studies have performed: Incremental PD has supportive observational and clinical practice data suggesting benefits, but randomized controlled evidence is limited, making this trial relatively novel and important.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Blacktown, New South Wales and 5 other locations
- Blacktown — Blacktown, New South Wales, Australia (Recruiting)
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (Not_yet_recruiting)
- Eastern Health — Box Hill, Victoria, Australia (Recruiting)
- Hallym University Sacred Heart Hospital — Chuncheon, Gangwon-do, South Korea (Recruiting)
- Taichung Veterans General Hospital — Taichung, Xitun District, Taiwan (Recruiting)
- King Chulalongkorn Memorial Hospital — Bangkok, Pathum Wan, Thailand (Recruiting)
Study contacts
- Study coordinator: Professor Yeoungjee Cho
- Email: yeoungjee.cho@health.qld.gov.au
- Phone: +61 7 3176 5080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.