Incremental PD With Single Icodextrin Exchange

NCT06119373 | Not Yet Recruiting DMC

• 1 other identifier: IIT-2022-0224
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives: To investigate the efficacy and safety of single daily icodextrin exchange for initiation of incremental peritoneal dialysis (PD). Subjects: Seventy-two incident PD patients. Methods: A single-center randomized controlled trial. Primary outcome: Change in residual kidney function in 48 weeks after recruitment.

Conditions

Peritoneal Dialysis Complication; Residual Kidney Function; Survival; Health-related Quality of Life

Outcome Measures

Primary Outcomes (1)

• Residual kidney function

  Change of residual kidney function in 48 weeks after PD initiation

  Up to 48 weeks after recruitment

Secondary Outcomes (6)

• Mortality

  Up to 48 weeks after recruitment

• Peritonitis-free survival

  Up to 48 weeks after recruitment

• Health-related quality of life

  Up to 48 weeks after recruitment

• Volume status

  Up to 48 weeks after recruitment

• Adequacy of small molecular solute clearance

  Up to 48 weeks after recuritment

Study Arms (2)

Single daily icodextrin exchange group

EXPERIMENTAL

For incident peritoneal dialysis (PD) patients assigned to the experimental arm, PD is initiated with single daily exchange of 2-liter icodextrin-based dialysis solution. The daily dwell time ranges from 8-24 hours per day, depending on the patient's clinical conditions. Additional exchange(s) of glucose-based dialysis solution will be added to increase uremic toxins and fluid removal if necessary during the follow-up.

Other: Single daily icodextrin exchange

Conventional PD group

ACTIVE COMPARATOR

For incident peritoneal dialysis (PD) patients assigned to this arm, PD is initiated with 2 to 3 exchanges of 2-liter glucose-based solution. The daily dwell time ranges from 8-24 hours per day, depending on the patient's clinical conditions. Additional exchange(s) of glucose-based dialysis solution will be added to increase uremic toxins and fluid removal if necessary during the follow-up.

Other: Conventional PD group

Interventions

Single daily icodextrin exchange OTHER

PD initiation with single daily exchange of 2-liter icodextrin-based dialysis solution.

Single daily icodextrin exchange group

Conventional PD group OTHER

PD is initiated with 2 to 3 exchanges of 2-liter glucose-based dialysis solution.

Conventional PD group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female patients aged 18 to 75 years;
• patients with chronic kidney disease stage 5 who are to start PD;
• eGFR ≥ 5 ml/min;
• urine output ≥ 800 ml/d.

You may not qualify if:

• documented anaphylaxis with icodextrin or glucose-based dialysate;
• concomitant severe chronic diseases such as malignancy, hepatitis, severe cardiac diseases, etc.;
• ongoing severe infection;
• planned or ongoing pregnancy or lactation;
• currently enrolled in other clinical studies;
• patients who have a life expectancy of \<12 months;
• refusal to give a written consent.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Officials

• Wei Fang, MD., PhD.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Yan, MD.

CONTACT

0086-13816588689; dryanhao@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: November 7, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 8, 2023

Record last verified: 2023-11