STarting incrEmental Prescription of Peritoneal Dialysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Incremental PD, Full dose PD.
- Who it may be relevant to
- Registry conditions: Peritoneal Dialysis (PD), Kidney Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, New Zealand, South Korea, Taiwan, Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Interventions
- 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. - 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)).
Primary outcome measures
- Quality of Life (QoL) [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (9)
- Residual Kidney Function (RKF) [Time frame: From enrollment to 3, 6, 9, 12 and 18 months]
- Anuria [Time frame: From enrollment to 3, 6, 9, 12 and 18 months]
- Serious adverse event [Time frame: Enrollment to 18 months]
- Death [Time frame: Enrollment to 18 months]
- Major cardiovascular event [Time frame: Enrollment to 18 months]
- Peritonitis [Time frame: Enrollment to 18 months]
- Non-elective hospitalisations [Time frame: Enrollment to 18 months]
- Hospitalisations [Time frame: Enrollment to 18 months]
- Quality of Life (QOL) and life participation [Time frame: Enrollment to 18 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- Blacktown — Blacktown
- Princess Alexandra Hospital — Brisbane
- Eastern Health — Box Hill
South Korea · 2 centers
- Hallym University Sacred Heart Hospital — Chuncheon
- Kyungpook National University — Daegu
Thailand · 2 centers
- Banphaeo General Hospital — Ban Phaeo
- King Chulalongkorn Memorial Hospital — Bangkok
New Zealand · 1 center
- Waitemata — Auckland
Taiwan · 1 center
- Taichung Veterans General Hospital — Taichung
Identifiers
NCT: NCT06642597 · AKTN 24.01