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
Principal Investigators: Associate Professor Yeoungjee Cho
Clinical Project Manager: Peta-Anne Paul-Brent
Clinical Research Associate: Lisan Mulvey
Trial Number: AKTN 24.01
Population: Adults commencing PD as their first dialysis therapy and able to give informed consent
Intervention:
- 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 (with option to have one day off/week) until an indication to increment the dose of PD (trigger point) is reached.
- Control: Participants randomised to the control group will commence full-dose PD according to site local practice.
Follow-up: 18 months
Primary outcome: Symptom burden-related Quality of Life (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) patient questionnaire.
Status: Recruiting.
Target Recruitment: Approx 224 participants globally.
Check out our STEP-PD trial videos for more information!
Trial Summary
PD is a flexible type of treatment that can be done at home. Most patients new to PD have some kidney function, which helps to manage fluid and toxins. Yet, more than 80% of people start with a standard full-dose schedule, which can be overwhelming.
There has been a growing interest to start PD using a lower dose and increase over time (known as incremental PD). Incremental PD may result in important savings for patients by reducing treatment time and cost.
Currently, there is no clinical trial evidence to confirm if it is better to start PD on a lower personalised dose. People with lived experience of PD support incremental PD. But they are concerned about worse symptoms from reduced fluid and toxin removal.
The STEP-PD trial is co-designed with consumers with lived experience of peritoneal dialysis (PD). This study aims to find out if incremental PD will provide the same or better quality of life after 6 months as starting with the full dose. It will also assess if incremental PD:
- reduces dialysis burden,
- is safe,
- is more environmentally sustainable,
- costs less for patients, the community and the healthcare system.
In this study, participants will either start PD with the standard full dose, or a personalised lower dose which will increment over time as needed.
The STEP-PD trial will help us find out if we can personalise the treatment of kidney failure.
The study has been funded by a NHMRC Investigator Grant.
Patient summary information about the STEP-PD trial
