STarting incrEmental Prescription of Peritoneal Dialysis

Not Applicable

Not yet recruiting

• Conditions: Peritoneal Dialysis (PD); Kidney Failure

• Registration Number: NCT06642597
• Lead Sponsor: The University of Queensland

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-13
• Last Update Submitted: 2024-10-13
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15
• Study Start: 2025-03-01
• Primary Completion: 2029-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Serious adverse event	Enrollment to 18 months	Number of category type of serious adverse events
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

Trial Locations

Locations (1)

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia