Health TrialsbyHealthPanel

STarting incrEmental Prescription of Peritoneal Dialysis

ConditionsPeritoneal Dialysis (PD)Kidney Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Queensland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adults (≥18 years) commencing PD as their first dialysis therapy (and been on dialysis for <1 month)

able to give informed consent

Disqualifiers

urine output <0.5L/day

previous kidney transplant

unlikely to be on dialysis for ≥1 year.

known or planned pregnancy during the trial

Trial design

Design model

Parallel

Treatments tested in this trial

  • Incremental PD

    Other intervention

    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.

  • Full dose PD

    Other intervention

    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)).

Treatment groups

224 Participants
are divided into 2 treatment groups
Group A: Incremental PDExperimental treatment 1 intervention
Group B: Full dose PDActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
From enrollment to the end of treatment at 6 months

Secondary outcomes

1

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

Time frame
From enrollment to 3, 6, 9, 12 and 18 months
2

Anuria

Proportion of patients with anuria (\<100mL/24h) at months 3, 6, 9, 12 and 18

Time frame
From enrollment to 3, 6, 9, 12 and 18 months
3

Serious adverse event

Number of category type of serious adverse events

Time frame
Enrollment to 18 months
4

Death

Time to all-cause mortality

Time frame
Enrollment to 18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Queensland

Lead sponsor

Source ClinicalTrials.gov
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