STarting incrEmental Prescription of Peritoneal Dialysis
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT06642597
Intervention or treatment
OTHER: Incremental PD
OTHER: Full dose PD
Conditions
- Peritoneal Dialysis (PD)
- Kidney Failure
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Princess Alexandra Hospital
Select from list below to view details:
Princess Alexandra Hospital
Brisbane, Queensland, Australia
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Who is running the clinical trial?
The University of Queensland
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Incremental PD
| Other: Incremental PD |
ACTIVE_COMPARATOR: Full dose PD
| Other: Full dose PD |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to the end of treatment at 6 months |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | From enrollment to 3, 6, 9, 12 and 18 months |
| Serious adverse event | Number of category type of serious adverse events | Enrollment to 18 months |
| Death | Time to all-cause mortality | Enrollment to 18 months |
| Major cardiovascular event | Time to first major cardiovascular event (defined as acute myocardial infarction) | Enrollment to 18 months |
| Peritonitis | Time to first peritonitis event | Enrollment to 18 months |
| Non-elective hospitalisations | Number of non-elective hospital admissions | Enrollment to 18 months |
| Hospitalisations | Hospitalisation for fluid overload, hyperkalaemia, or uraemic complications; episodes of hyperkalaemia (≥6mmol/L) | 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) | Enrollment to 18 months |
References
Clinical Trials Gov: STarting incrEmental Prescription of Peritoneal DialysisOther trials to consider
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