Peritoneal Dialysis Daily Versus Six Days Per Week | NCT06399848

Studies
Peritoneal Dialysis Daily Versus Six Days Per Week

NCT06399848

Sponsor

Stanford University

Status

Withdrawn

Last Update Posted

May 22, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Peritoneal Dialysis

Interventions

Skip one day of peritoneal dialysis treatment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was not funded.

Expanded Access Info

Start Date

Jul 2024Estimated

Primary Completion Date

Jun 2025Estimated

Completion Date

Jun 2025Estimated

First Submitted Date

Apr 28, 2024

First Submission Date that Met QC Criteria

May 2, 2024

First Posted Date

May 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2025

Last Update Posted Date

May 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: Skip one day of peritoneal dialysis treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Skip one day of peritoneal dialysis treatment	Other	Skip one day of peritoneal dialysis treatment	Peritoneal Dialysis Daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient's preference for treatment regimen	Patient's stated preference for dialysis daily versus six days per week	Two weeks per patient

Secondary Outcomes

Measure	Description	Time Frame
Symptoms	Quality of Life as assessed by a questionnaire	Two weeks per patient
Plasma solute levels	Plasma levels of urea nitrogen and creatinine.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Daily treament with peritoneal dialysis and residual native kidney funciton with residual urea clearance greater than 2 ml/min.

Exclusion Criteria:

less than 3 months on peritoneal dialysis
recent change in the dialysis prescriptoin
recent peritonitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C466999	SPHKAP protein, human

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided