An interventional study of Incremental PD and Full dose PD in Peritoneal Dialysis (PD) and Kidney Failure, sponsored by The University of Queensland. Recruiting at 14 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by The University of Queensland · Not applicable, Interventional, and Treatment
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.
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.
1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.
This study's planned enrollment of 224 is above the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →The University of Queensland is the lead sponsor of 91 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: Incremental 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)).
Other: Full dose 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.
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)).
Quality of Life (QoL)
Symptom burden-related 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).
Time frame: From enrollment to the end of treatment at 6 months
Residual Kidney Function (RKF)
Slope of RKF decline over time modelled with linear regression of the arithmetic means of 24-hour urinary urea and creatinine clearances at months 3, 6, 9, 12 and 18
Time frame: From enrollment to 3, 6, 9, 12 and 18 months
Anuria
Proportion of patients with anuria (\<100mL/24h) at months 3, 6, 9, 12 and 18
Time frame: From enrollment to 3, 6, 9, 12 and 18 months
Serious adverse event
Number of category type of serious adverse events
Time frame: Enrollment to 18 months
Death
Time to all-cause mortality
Time frame: Enrollment to 18 months
Major cardiovascular event
Time to first major cardiovascular event (defined as acute myocardial infarction)
Time frame: Enrollment to 18 months
Peritonitis
Time to first peritonitis event
Time frame: Enrollment to 18 months
Non-elective hospitalisations
Number of non-elective hospital admissions
Time frame: Enrollment to 18 months
Hospitalisations
Hospitalisation for fluid overload, hyperkalaemia, or uraemic complications; episodes of hyperkalaemia (≥6mmol/L)
Time frame: Enrollment to 18 months
Quality of Life (QOL) and life participation
QOL and life participation: quarterly KDQOL-36 (physical and mental composite scores; effects and burden of kidney disease) and the SF6D (a component of the KDQOL)
Time frame: Enrollment to 18 months
Plan to share: Yes — Data sets will be made available to researchers within STEP-PD for analysis of sub-studies and country-specific outcomes after the primary manuscript has been accepted for publication. For researchers outside STEP-PD, individual participant data will be made available upon request to a Data Access Committee, a review board set up to assess proposals based on sound science, benefit-risk balancing, and research team expertise. Ethics approval will be required. This process will be in effect for a period of 2 to 5 years following publication of the main study results.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: A period of 2 to 5 years following publication of the main study results.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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