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The Difference Between Daily and Alternative Day Use of Icodextrin

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05943470
Collaborator
(none)
74
Enrollment
2
Arms
16.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Icodextrin Peritoneal Dialysis Solution
 Phase 4

Detailed Description

  1. Patients who met the inclusion criteria will be enrolled in this study.

  2. Randomization.

  3. Treatment A: daily icodextrin for 2 weeks. Treatment B: icodextrin is used every other day and original glucose-based dialysate is used every other day for a total of 2 weeks. The duration of icodextrin exchange is unchanged from the participants' original dialysate exchange regimen (typically, 8 to 14 hours). The interval is two weeks (the original dialysate was resumed). Participants would receive treatment A-B or B-A, depending on randomization.

  4. Participants would record daily peritoneal ultrafiltration volume, long dwell ultrafiltration volume, dialysis prescription, urine volume, body weight, home blood pressure monitoring and complaints of discomfort.

  5. Before the start of treatment (day 0), after the end of treatment period 1 (day14), at the end of washout period (day28), and at the end of treatment period 2 (day42), blood samples are collected for blood glucose, blood lipids, BNP, amylase, blood electrolytes, alkaline phosphatase. The participants' weight, blood pressure, dialysis prescription, daily ultrafiltration volume, urine volume, long dwell ultrafiltration volume and BCM measurement results would be recorded on the visit day. In the last 10 enrolled patients, blood samples would be collected for detection of icodextrin metabolites. After the end of treatment period 2, participants could choose the prescription of dialysate according to their own wishes and would be followed up for another 2 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Difference Between Daily and Alternative Day Use of Icodextrin in Peritoneal Dialysis
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: daily

daily use of one exchange of icodextin as long dwell

Drug: Icodextrin Peritoneal Dialysis Solution
alternative day use of icodextrin comparing with daily use of icodextrin
Other Names:
  • Extraneal

    		•
    Experimental: alternative day

    alternative day use of one exchange of icodextin as long dwell

    Drug: Icodextrin Peritoneal Dialysis Solution
    alternative day use of icodextrin comparing with daily use of icodextrin
    Other Names:
  • Extraneal

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ultrafiltration measured in ml [2 weeks]

      ultrafiltration volume for single icodextrin dwell

    Secondary Outcome Measures

    1. daily treatment cost measured in Chinese Yuan [2 weeks]

      daily treatment cost

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. End-stage renal failure

    1. Patients with regular peritoneal dialysis in our center

    2. 18-75 years old

    3. Patients who currently use glucose dialysate for prolonged abdominals

    4. Sign informed consent

    Exclusion Criteria:
      1. The expected survival time is less than 3 months

    1. Known peritoneal dialysis tube dysfunction

    2. Peritonitis occurred within one month

    3. Known peritoneal effusion

    4. Known allergy to icodextrin

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zanzhe Yu, Principal investigator, RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05943470
    Other Study ID Numbers:
    • LY2023-083
    First Posted:
    Jul 13, 2023
    Last Update Posted:
    Jul 13, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Icodextrin
    Dialysis Solutions

    Study Results

    No Results Posted as of Jul 13, 2023