Kidney Failure, Peritoneal Dialysis (PD)
Conditions
Keywords
Kidney failure, Kidney disease, peritoneal dialysis, incremental start PD
Brief summary
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
OTHERIncremental 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.
OTHERFull 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)).
Sponsors
The University of Queensland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Multicentre, prospective, adaptive, randomised, open-label, parallel group, non-inferiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) | From enrollment to the end of treatment at 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual Kidney Function (RKF) | From enrollment to 3, 6, 9, 12 and 18 months | 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 |
| Anuria | From enrollment to 3, 6, 9, 12 and 18 months | Proportion of patients with anuria (\<100mL/24h) at months 3, 6, 9, 12 and 18 |
| Serious adverse event | Enrollment to 18 months | Number of category type of serious adverse events |
| Death | Enrollment to 18 months | Time to all-cause mortality |
| Major cardiovascular event | Enrollment to 18 months | Time to first major cardiovascular event (defined as acute myocardial infarction) |
| Peritonitis | Enrollment to 18 months | Time to first peritonitis event |
| Non-elective hospitalisations | Enrollment to 18 months | Number of non-elective hospital admissions |
| Hospitalisations | Enrollment to 18 months | Hospitalisation for fluid overload, hyperkalaemia, or uraemic complications; episodes of hyperkalaemia (≥6mmol/L) |
| Quality of Life (QOL) and life participation | Enrollment to 18 months | 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) |
Countries
Australia, New Zealand, South Korea, Taiwan, Thailand
Contacts
CONTACTProfessor Yeoungjee Cho
CONTACTLaura Hickey
Outcome results
None listed