Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal Dialysis

NCT05721404 | Recruiting Phase 4

• 1 other identifier: [2022]042
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize incremental peritoneal dialysis (incremental PD) protocol with icodextrin solution will help patients to achieve adequate ultrafiltration and adequate dialysis with less glucose exposure by manipulating a low frequency of exchanges, therefore prolong the time from incremental protocol to full dose protocol (Full dose dialysis is defined as a dialysis dose of more than 8 L (4 exchanges of 2 L) per day). The goal of this clinical trial is to investigate the effect of icodextrin postponing the shift of low dose to full dose dialysis in the first year of incremental peritoneal dialysis. The main questions are:

• The effect of icodextrin on the shift of low dose to full dose dialysis in the first year in patients on incremental peritoneal dialysis.
• The effect of icodextrin on clinical outcomes in patients on incremental peritoneal dialysis, such as the first episode of peritonitis, the incidence of anuria, the first incidence of hospitalization, technical failure, all cause mortality, cardiovascular disease free survival and the quality of life. Participants will be 1:1 randomized to the ICO (icodextrin) arm and CON (control) arm. Both arms patients will be followed every 2 months for fluid status by bioimpedance analysis. An extracellular water /total body water (ECW/TBW) ≥ 0.40 or edema is defined as overhydration (OH). The OH patients in the ICO arm will be prescribed icodextrin (Extraneal) for long night dwell to improve fluid overload till their re-measurement of ECW/TBW \< 0.40 or edema disappeared. The OH patients in the CON arm will be prescribed hypertonic Dextrose solution for long night dwell to improve fluid overload till their ECW/TBW \< 0.40 or edema disappeared. Researchers will compare the time of transferring from low dose PD to full dose and the clinical outcomes in the first year between the patients in ICO and CON groups to see the effect of icodextrin on the shift of low dose to full dose dialysis and clinical outcomes in the first year in patients on incremental peritoneal dialysis. Successful completion of the study will advance our strategy of incremental PD and help to prolong the shift from incremental to full dose dialysis, and offer new opportunities for the development of an effective and economical therapy for PD patients with residual kidney function (RKF)

Conditions

Peritoneal Dialysis

Keywords

peritoneal dialysis; incremental peritoneal dialysis; icodextrin

Outcome Measures

Primary Outcomes (1)

• The time that transferring from incremental PD to full dose in the first year of incremental PD

  The time of transferring to full dose dialysis was subtracted from the time of andomization

  From date of randomization until the date of transferring from incremental PD to full dose, assessed up to 12 months

Secondary Outcomes (7)

• The time of the first episode of peritonitis

  From date of randomization until the date of first documented date of peritonitis, whichever came first, assessed up to 12 months

• The time of the incidence of anuria

  From date of randomization until the date of first documented date of anuria, whichever came first, assessed up to 12 months

• The time of the first incidence of hospitalization

  From date of randomization until the date of first documented date of hospitalization, whichever came first, assessed up to 12 months

• The time of technical failure (transferring to HD)

  From date of randomization until the date of first documented date of technical failure (transferring to HD), whichever came first, assessed up to 12 months

• All cause mortality and cardiovascular mortality

  From date of randomization until the date of documented date of death due to cardiovascular cause and other causes, assessed up to 12 months

Study Arms (2)

ICO (icodextrin)

EXPERIMENTAL

When the extracellular water /total body water (ECW/TBW) ≥ 0.40, the patients in the ICO arm will be prescribed icodextrin (Extraneal) for long night dwell to improve fluid overload till their re-measurement of ECW/TBW \< 0.40.

Drug: Icodextrin Peritoneal Dialysis Solution

CON (control)

OTHER

When the extracellular water /total body water (ECW/TBW) ≥ 0.40, the patients in the CON arm will be prescribed hypertonic Dextrose solution for long night dwell to improve fluid overload till their ECW/TBW \< 0.40

Drug: Hypertonic Dextrose solution

Interventions

Icodextrin Peritoneal Dialysis Solution DRUG

Icodextrin (Extraneal) for long night dwell

ICO (icodextrin)

Hypertonic Dextrose solution DRUG

Hypertonic Dextrose solution for long night dwell

CON (control)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old;
• The estimated glomerular filtration rate (eGFR) ≥ 3ml/min·1.73m2 when enrolled;
• The 24-hour urine volume ≥ 500ml when enrolled;
• The patient or his lawful representative is able to receive and complete training of home peritoneal dialysis;
• Patients were able to follow the follow-up schedule and other requirements of the study;
• Patients can come to the peritoneal dialysis center for regular follow-up (once every 2 months or more);
• Participants were expected to remain on peritoneal dialysis for at least 13 months;
• Patients with good compliance;
• Informed consent was obtained.

You may not qualify if:

• Treated with both peritoneal dialysis and hemodialysis;
• Patients who have previously received a kidney transplant and have been receiving immunosuppressive therapy;
• Contraindications to bioelectrical impedance analysis (BIA) testing (e.g., amputation, use of a pacemaker or prosthesis);
• Allergy to Icodextrin, starch and starch products, or suffer from glycogen storage disease;
• Contraindications for the use of icodextrin;
• HIV-positive participants;
• Patients with tumors or other serious diseases have a life expectancy of less than one year;
• Mental illness that interferes with the patient's understanding of the test requirements and completion of the test process;
• Chronic wasting diseases such as tuberculosis, cirrhosis, hematological or other malignancies;
• Patients who are pregnant, intending to become pregnant, or breastfeeding during the study period;
• The patients had a history of drug abuse or alcoholism 2 years before the screening period;
• Patients who are unwilling or not expected to fully comply with the visits and evaluations required by the protocol;
• Patients who, in the investigator's judgment, have other serious or acute medical conditions that may prevent them from participating in the study.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (15)

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Study Officials

• Xiao Yang, Doctor

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Yang, Doctor

CONTACT

0086-20-87608879; yxiao@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 10, 2023
• Study Start: May 24, 2023
• Primary Completion: April 28, 2025
• Study Completion: December 31, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)