Starting peritoneal dialysis gradually with an incremental prescription
Official 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
Run by The University of Queensland · NCT06642597 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 224 (estimated) |
| Sponsor | The University of Queensland Academic / other |
| Locations | 14 sites (Blacktown, New South Wales and 13 other locations) |
| Status | Recruiting |
| Started | September 19, 2025 |
| Main results expected | September 30, 2029 |
| Study ends | September 30, 2029 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT06642597 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Incremental PD has supportive observational and clinical practice data suggesting benefits, but randomized controlled evidence is limited, making this trial relatively novel and important.
Who can join: the full rules
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 it's running
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Blacktown
Blacktown, New South Wales, Australia Recruiting -
Eastern Health
Box Hill, Victoria, Australia Recruiting -
Waitemata
Auckland, New Zealand Recruiting -
Hallym University Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea Recruiting -
Kyungpook National University Chilgok Hospital
Daegu, South Korea Recruiting -
Kyungpook National University
Daegu, South Korea Recruiting
Show 8 more locations
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Taichung Veterans General Hospital
Taichung, Xitun District, Taiwan Recruiting -
Banphaeo General Hospital
Ban Phaeo, Changwat Samut Sakhon, Thailand Recruiting -
Samut Prakan Hospital
Mueang Samut Prakan, Mueang Samut Prakan District, Thailand Recruiting -
King Chulalongkorn Memorial Hospital
Bangkok, Pathum Wan, Thailand Recruiting -
John hunter Hospital
Newcastle, New South Wales, Australia Not yet recruiting -
Wollongong Hospital
Wollongong, New South Wales, Australia Not yet recruiting -
Princess Alexandra Hospital
Brisbane, Queensland, Australia Not yet recruiting -
Nakhon Pathom Hospital
Nakhon Pathom, Mueang Nakhon Pathom District, Thailand Not yet recruiting
Study contacts
- Study coordinator: Professor Yeoungjee Cho
- Email: yeoungjee.cho@health.qld.gov.au
- Phone: +61 7 3176 5080
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Guiding Optimal Blood Pressure in Peritoneal Dialysis
This pilot tests whether aiming for a lower systolic blood pressure target (<120 mmHg) is feasible and practical for adults with end-stage kidney disease on peritoneal dialysis, compared to a <140 mmHg target.
-
Omnisol-preserved kidneys before transplant (hypothermic machine perfusion)
This study tests whether using Omnisol during hypothermic machine perfusion before kidney transplant can improve early graft function compared with standard preservation.
-
Synbiotic capsules for adults on peritoneal dialysis
This study tests whether daily synbiotic capsules can reduce inflammation and improve nutrition in adults with CKD on peritoneal dialysis compared with a placebo.
-
Kidney and liver blood flow patterns after major trauma
We will use bedside ultrasound to see whether abnormal kidney and liver blood flow patterns occur in adults admitted to the ICU after major trauma and whether those patterns link to acute kidney injury or the need for mechanical ventilation.
-
Home-based exercise to boost fitness for people waiting for a kidney transplant
This study tests whether a 12-week, home-based exercise program plus a wearable activity tracker helps adults on the kidney transplant waiting list increase daily activity and improve physical function.
-
MiDiálisis mobile app with Bluetooth scale and smartband for people on peritoneal dialysis
This pilot will try a smartphone app plus a Bluetooth scale and smartband to help adults on peritoneal dialysis track weight, vitals, and activity and share the data with their care team.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.