The Difference Between Daily and Alternative Day Use of Icodextrin

The Difference Between Daily and Alternative Day Use of Icodextrin in Peritoneal Dialysis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peritoneal Dialysis Solution Adverse Reaction
• Intervention / Treatment: Drug: Icodextrin Peritoneal Dialysis Solution

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 Type: Interventional
• Enrollment (Estimated): 74
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. End-stage renal failure

  2. Patients with regular peritoneal dialysis in our center

  3. 18-75 years old

  4. Patients who currently use glucose dialysate for prolonged abdominals

  5. Sign informed consent

Exclusion Criteria:

• 1. The expected survival time is less than 3 months

  2. Known peritoneal dialysis tube dysfunction

  3. Peritonitis occurred within one month

  4. Known peritoneal effusion

  5. Known allergy to icodextrin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ultrafiltration measured in ml	ultrafiltration volume for single icodextrin dwell	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
daily treatment cost measured in Chinese Yuan	daily treatment cost	2 weeks

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 28, 2024

Study Registration Dates

• First Submitted: June 11, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Dialysis Solutions; Icodextrin
• Other Study ID Numbers: LY2023-083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No