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STarting incrEmental Prescription of Peritoneal Dialysis

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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.

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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.

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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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2025-03-01

    Primary completion: 2029-09-30

    Study completion finish: 2029-09-30

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT06642597

    Intervention or treatment

    OTHER: Incremental PD

    OTHER: Full dose PD

    Conditions

    • Kidney Failure
    • Peritoneal Dialysis (PD)

    Find a site

    Closest Location:

    Princess Alexandra Hospital

    Research sites nearby

    Select from list below to view details:

    • Princess Alexandra Hospital

      Brisbane, Queensland, Australia

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    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/ArmIntervention/Treatment
    EXPERIMENTAL: Incremental 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.
    OTHER: Incremental 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.
    ACTIVE_COMPARATOR: Full 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)).
    OTHER: Full 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)).

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome 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

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome 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 18From enrollment to 3, 6, 9, 12 and 18 months
    AnuriaProportion of patients with anuria (\<100mL/24h) at months 3, 6, 9, 12 and 18From enrollment to 3, 6, 9, 12 and 18 months
    Serious adverse eventNumber of category type of serious adverse eventsEnrollment to 18 months
    DeathTime to all-cause mortalityEnrollment to 18 months
    Major cardiovascular eventTime to first major cardiovascular event (defined as acute myocardial infarction)Enrollment to 18 months
    PeritonitisTime to first peritonitis eventEnrollment to 18 months
    Non-elective hospitalisationsNumber of non-elective hospital admissionsEnrollment to 18 months
    HospitalisationsHospitalisation for fluid overload, hyperkalaemia, or uraemic complications; episodes of hyperkalaemia (≥6mmol/L)Enrollment to 18 months
    Quality of Life (QOL) and life participationQOL 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

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

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    References

    Clinical Trials Gov: STarting incrEmental Prescription of Peritoneal Dialysis

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