NCT05943470

Brief Summary

Volume overload is an important cause of technical failure in peritoneal dialysis patients. Icodextrin can provide continuous ultrafiltration, which provides a new option for peritoneal dialysis patients. However, icodextrin metabolites are known to accumulate to some extent in the body, resulting in less ultrafiltration with long-term icodextrin use comparing with newly use. Therefore, the investigator hypothesized that a single dose of icodextrin would produce more ultrafiltration volume with the use of icodextrin dialysate on alternate days than with the use of icodextrin dialysate on daily uses.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2023

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2024

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

June 11, 2023

Last Update Submit

July 12, 2023

Conditions

Peritoneal Dialysis Solution Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • ultrafiltration measured in ml

    ultrafiltration volume for single icodextrin dwell

    2 weeks

Secondary Outcomes (1)

  • daily treatment cost measured in Chinese Yuan

    2 weeks

Study Arms (2)

daily

ACTIVE COMPARATOR

daily use of one exchange of icodextin as long dwell

Drug: Icodextrin Peritoneal Dialysis Solution

alternative day

EXPERIMENTAL

alternative day use of one exchange of icodextin as long dwell

Drug: Icodextrin Peritoneal Dialysis Solution

Interventions

Icodextrin Peritoneal Dialysis SolutionDRUG

alternative day use of icodextrin comparing with daily use of icodextrin

Also known as: Extraneal
alternative daydaily

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. End-stage renal failure
  • \. Patients with regular peritoneal dialysis in our center
  • \. 18-75 years old
  • \. Patients who currently use glucose dialysate for prolonged abdominals
  • \. Sign informed consent

You may not qualify if:

  • \. The expected survival time is less than 3 months
  • \. Known peritoneal dialysis tube dysfunction
  • \. Peritonitis occurred within one month
  • \. Known peritoneal effusion
  • \. Known allergy to icodextrin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Icodextrin

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 11, 2023

First Posted

July 13, 2023

Study Start

August 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 28, 2024

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share