NCT06399848

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2024

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

April 28, 2024

Last Update Submit

May 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient's preference for treatment regimen

    Patient's stated preference for dialysis daily versus six days per week

    Two weeks per patient

Secondary Outcomes (2)

  • Symptoms

    Two weeks per patient

  • Plasma solute levels

    Two weeks per patient

Study Arms (1)

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

Skip one day of peritoneal dialysis treatment

Peritoneal Dialysis Daily

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

SPHKAP protein, human
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 28, 2024

First Posted

May 6, 2024

Study Start

July 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

May 22, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share