Peritoneal DialysisNCT06399848
Peritoneal Dialysis Daily Versus Six Days Per Week
A study testing Skip one day of peritoneal dialysis treatment in people with Peritoneal Dialysis, run by Stanford University.
Trial summary
The study will enroll patients receiving daily peritoneal dialysis who have significant residual native kidney function. The investiators will visit the patients at a routinely scheduled clinic visit and again at a non-routine visit after the patients skip a single day of dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis
- What is being tested?
- Skip one day of peritoneal dialysis treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Daily treament with peritoneal dialysis and residual native kidney funciton with residual urea clearance greater than 2 ml/min.
Who cannot join
- less than 3 months on peritoneal dialysis
- recent change in the dialysis prescriptoin
- recent peritonitis
About this study
The study will enroll patients receiving daily peritoneal dialysis who have significant residual native kidney function. The investiators will visit the patients at a routinely scheduled clinic visit and again at a non-routine visit after the patients skip a single day of dialysis. Blood samples will be obtained and a quality of life questionnaire will be administered at both visits.
The primary aim will be to determine whether the patients would prefer daily treatment or being allowed to skip one day per week.
Other aims will be to determine the effect of skipping a day on plasma levels of urea nitrogen and creatinine.
Read the detailed description
The patients' preference will be assessed by asking the simple question would you prefer to perform peritoneal dialysis daily of six days per week.
The quality of life questionnaire to be used will be the Dialysis Symptom Index (DSI) which has a range of 0 to 150 with a high score reflecting worse quality of life.
The chemical to be measured will be the plasma urea nitrogen in mg/dl and the plasma creatinine in mg/dl as measured by the clinical laboratory.
- Conditions
- Peritoneal Dialysis
- Being tested
- Skip one day of peritoneal dialysis treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skip one day of peritoneal dialysis treatmentOther
Skip one day of peritoneal dialysis treatment
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal Dialysis Daily | Other | Each patient will compare their regular daily treatment with the effect of skipping a single day of treatment. There will be no other intervention. Receives: Other: Skip one day of peritoneal dialysis treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's preference for treatment regimen
Patient's stated preference for dialysis daily versus six days per week
Measured: Two weeks per patient
Secondary outcomes (2)
Symptoms
Quality of Life as assessed by a questionnaire
Measured: Two weeks per patient
Plasma solute levels
Plasma levels of urea nitrogen and creatinine.
Measured: Two weeks per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study startJul 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: Study was not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Meyer, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399848
- Sponsor's protocol ID
- 75365
- Status last verified
- May 2024
- First submitted
- 28 Apr 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peritoneal Dialysis Daily Versus Six Days Per Week
- ClinicalTrials.gov ID
- NCT06399848
- Acronym / sponsor ID
- 75365
- Conditions
- Peritoneal Dialysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 6 May 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.
The study will enroll patients receiving daily peritoneal dialysis who have significant residual native kidney function. The investiators will visit the patients at a routinely scheduled clinic visit and again at a non-routine visit after the patients skip a single day of dialysis. Blood samples will be obtained and a quality of life questionnaire will be administered at both visits.
The primary aim will be to determine whether the patients would prefer daily treatment or being allowed to skip one day per week.
Other aims will be to determine the effect of skipping a day on plasma levels of urea nitrogen and creatinine.
Detailed description
The patients' preference will be assessed by asking the simple question would you prefer to perform peritoneal dialysis daily of six days per week.
The quality of life questionnaire to be used will be the Dialysis Symptom Index (DSI) which has a range of 0 to 150 with a high score reflecting worse quality of life.
The chemical to be measured will be the plasma urea nitrogen in mg/dl and the plasma creatinine in mg/dl as measured by the clinical laboratory.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peritoneal Dialysis Daily | Other | Other: Skip one day of peritoneal dialysis treatmentEach patient will compare their regular daily treatment with the effect of skipping a single day of treatment. There will be no other intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Daily treament with peritoneal dialysis and residual native kidney funciton with residual urea clearance greater than 2 ml/min.
Key exclusion criteria (3 listed)
- less than 3 months on peritoneal dialysis
- recent change in the dialysis prescriptoin
- recent peritonitis
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 |
|---|---|---|
| Skip one day of peritoneal dialysis treatmentSkip one day of peritoneal dialysis treatment | Other | Peritoneal Dialysis Daily |
Primary outcome
Patient's preference for treatment regimen
Time frame: Two weeks per patient
Patient's stated preference for dialysis daily versus six days per week
2 secondary outcomes
Symptoms
Time frame: Two weeks per patient
Plasma solute levels
Time frame: Two weeks per patient
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Iodine Starch Test Use in Pleuroperitoneal Leak
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Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Skip one day of peritoneal dialysis treatment in people with Peritoneal Dialysis, run by Stanford University.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's preference for treatment regimen (time frame: Two weeks per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2025.