Peritoneal Dialysis (PD)STEP-PDNCT06642597
STarting incrEmental Prescription of Peritoneal Dialysis
A study testing Incremental PD and Full dose PD in people with Peritoneal Dialysis (PD) and Kidney Failure, run by The University of Queensland at 14 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis (PD), Kidney Failure
- What is being tested?
- Incremental PD and Full dose PD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 19 Sep 2025to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (≥18 years) commencing PD as their first dialysis therapy (and been on dialysis for <1 month)
- able to give informed consent
Who cannot join
- urine output <0.5L/day
- previous kidney transplant
- unlikely to be on dialysis for ≥1 year.
- known or planned pregnancy during the trial
Trial locations and contacts
14 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 5 countries
Australia5 sites, 5 recruiting
- Recruiting
Blacktown
Blacktown, New South Wales, 2148
Katrina Chau, Associate Professor, +61 28670 8330, Katrina.Chau@health.nsw.gov.au
- Recruiting
Eastern Health
Box Hill, Victoria, 3218
Louis Huang, +610398957642, louis.huang@monash.edu
- Not yet recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Yeoungjee Cho, yeoungjee.cho@health.qld.gov.au
- Not yet recruiting
John hunter Hospital
Newcastle, New South Wales, 2305
Pedro F Gois, A/Prof, +610249213545, pedro.francagois@health.nsw.gov.au
- Not yet recruiting
Wollongong Hospital
Wollongong, New South Wales, 2500
Jenny HC Chen, Doctor, 0242225372, JennyHengChen.Chen@health.nsw.gov.au
Thailand4 sites, 4 recruiting
- Recruiting
Banphaeo General Hospital
Ban Phaeo, Changwat Samut Sakhon, 74120
Talerngsak Kanjanabuch, +66 34 419 555, golfnephro@hotmail.com
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, Pathum Wan, 10330
Talerngsak Kanjanabuch, 662-256-4251, golfnephro@hotmail.com
- Recruiting
Samut Prakan Hospital
Mueang Samut Prakan, Mueang Samut Prakan District, 10270
Talerngsak Kanjanabuch, Professor, 662-256-4251, golfnephro@hotmail.com
- Not yet recruiting
Nakhon Pathom Hospital
Nakhon Pathom, Mueang Nakhon Pathom District, 73000
Talerngsak Kanjanabuch, Professor, 662-256-4251, golfnephro@hotmail.com
South Korea3 sites, 3 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Chuncheon, Gangwon-do, 14068
Jwa-Kyung Kim, Professor, 82-31-380-3720, jwa816@naver.com
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu
Jang Hee Cho, Professor, +82 53-950-5114, jh-cho@knu.ac.kr
- Recruiting
Kyungpook National University
Daegu
Jang Hee Cho, +82 53-950-5114, jh-cho@knu.ac.kr
New Zealand1 site, 1 recruiting
- Recruiting
Waitemata
Auckland, 0610
Emad Maher, (09) 486 8305, Emad.Maher@waitematadhb.govt.nz
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, Xitun District, 1650
Mu Chi Chung, Associate Professor, mcchung0322@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Peritoneal Dialysis (PD), Kidney Failure
- Being tested
- Incremental PD, Full dose PD
- Keywords
- Kidney failure, Kidney disease, peritoneal dialysis, incremental start PD
- Medical subject headings
- Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental PDOther
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 PDOther
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)).
| Study group | Role | What they receive |
|---|---|---|
| Incremental PD | Experimental | 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. Receives: Other: Incremental PD |
| Full dose PD | Active comparator | 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)). Receives: Other: Full dose PD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (9)
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
Measured: From enrollment to 3, 6, 9, 12 and 18 months
Anuria
Proportion of patients with anuria (<100mL/24h) at months 3, 6, 9, 12 and 18
Measured: From enrollment to 3, 6, 9, 12 and 18 months
Serious adverse event
Number of category type of serious adverse events
Measured: Enrollment to 18 months
Death
Time to all-cause mortality
Measured: Enrollment to 18 months
Major cardiovascular event
Time to first major cardiovascular event (defined as acute myocardial infarction)
Measured: Enrollment to 18 months
Peritonitis
Time to first peritonitis event
Measured: Enrollment to 18 months
Non-elective hospitalisations
Number of non-elective hospital admissions
Measured: Enrollment to 18 months
Hospitalisations
Hospitalisation for fluid overload, hyperkalaemia, or uraemic complications; episodes of hyperkalaemia (≥6mmol/L)
Measured: Enrollment to 18 months
Quality of Life (QOL) and life participation
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)
Measured: Enrollment to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start19 Sep 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal Dialysis (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, prospective, adaptive, randomised, open-label, parallel group, non-inferiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642597
- Sponsor's protocol ID
- AKTN 24.01
- Acronym
- STEP-PD
- Status last verified
- Jan 2026
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sets will be made available to researchers within STEP-PD for analysis of sub-studies and country-specific outcomes after the primary manuscript has been accepted for publication. For researchers outside STEP-PD, individual participant data will be made available upon request to a Data Access Committee, a review board set up to assess proposals based on sound science, benefit-risk balancing, and research team expertise. Ethics approval will be required. This process will be in effect for a period of 2 to 5 years following publication of the main study results.
Publications
Burnett CT, McGrath S, Kanjanabuch T, Johnson DW, Cho Y, Jain AK. Perceptions and Patterns Associated with Incremental Peritoneal Dialysis Use: Surveying Physicians and Nurses across Australia, Canada, and Thailand. Clin J Am Soc Nephrol. 2026 Jul 29. doi: 10.2215/CJN.0000001128. Online ahead of print.
PubMed 42525796
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06642597
- Acronym / sponsor ID
- STEP-PD / AKTN 24.01
- Conditions
- Peritoneal Dialysis (PD), Kidney Failure
- Keywords
- Kidney failure, Kidney disease, peritoneal dialysis, incremental start PD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, prospective, adaptive, randomised, open-label, parallel group, non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Incremental PD | Experimental | Other: Incremental PDIncremental 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 | Active comparator | Other: Full dose PDFull 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)). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults (≥18 years) commencing PD as their first dialysis therapy (and been on dialysis for <1 month)
- able to give informed consent
Key exclusion criteria (4 listed)
- urine output <0.5L/day
- previous kidney transplant
- unlikely to be on dialysis for ≥1 year.
- known or planned pregnancy during the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incremental PDIncremental 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 |
| Full dose PDFull 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 |
Primary outcome
Quality of Life (QoL)
Time frame: 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).
9 secondary outcomes
Residual Kidney Function (RKF)
Time frame: From enrollment to 3, 6, 9, 12 and 18 months
Anuria
Time frame: From enrollment to 3, 6, 9, 12 and 18 months
Serious adverse event
Time frame: Enrollment to 18 months
Death
Time frame: Enrollment to 18 months
Major cardiovascular event
Time frame: Enrollment to 18 months
Peritonitis
Time frame: Enrollment to 18 months
Non-elective hospitalisations
Time frame: Enrollment to 18 months
Hospitalisations
Time frame: Enrollment to 18 months
Quality of Life (QOL) and life participation
Time frame: Enrollment to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Derived from this study: PubMed 42525796Burnett CT, McGrath S, Kanjanabuch T, Johnson DW, Cho Y, Jain AK. Perceptions and Patterns Associated with Incremental Peritoneal Dialysis Use: Surveying Physicians and Nurses across Australia, Canada, and Thailand. Clin J Am Soc Nephrol. 2026 Jul 29. doi: 10.2215/CJN.0000001128. Online ahead of print.
- Individual participant dataSharing planned: Yes. Data sets will be made available to researchers within STEP-PD for analysis of sub-studies and country-specific outcomes after the primary manuscript has been accepted for publication. For researchers outside STEP-PD, individual participant data will be made available upon request to a Data Access Committee, a review board set up to assess proposals based on sound science, benefit-risk balancing, and research team expertise. Ethics approval will be required. This process will be in effect for a period of 2 to 5 years following publication of the main study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incremental PD and Full dose PD in people with Peritoneal Dialysis (PD) and Kidney Failure, run by The University of Queensland at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Australia, Thailand, South Korea, New Zealand, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Yeoungjee Cho (+61 7 3176 5080, yeoungjee.cho@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoL) (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06642597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.