Clinical trial NCT06642597: STarting incrEmental Prescription of Peritoneal Dialysis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peritoneal Dialysis (PD)
Kidney Failure
Keywords: Kidney failure
Kidney disease
peritoneal dialysis
incremental start PD
Lead sponsor: The University of Queensland
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre, prospective, adaptive, randomised, open-label, parallel group, non-inferiority trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of Life (QoL)
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: Residual Kidney Function (RKF)
timeFrame: From enrollment to 3, 6, 9, 12 and 18 months
measure: Anuria
timeFrame: From enrollment to 3, 6, 9, 12 and 18 months
measure: Serious adverse event
timeFrame: Enrollment to 18 months
measure: Death
timeFrame: Enrollment to 18 months
measure: Major cardiovascular event
timeFrame: Enrollment to 18 months
measure: Peritonitis
timeFrame: Enrollment to 18 months
measure: Non-elective hospitalisations
timeFrame: Enrollment to 18 months
measure: Hospitalisations
timeFrame: Enrollment to 18 months
measure: Quality of Life (QOL) and life participation
timeFrame: Enrollment to 18 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
Study officials:
References: