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

ConditionPeritoneal Dialysis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Icodextrin Peritoneal Dialysis Solution

    Drug

    Icodextrin (Extraneal) for long night dwell

  • Hypertonic Dextrose solution

    Drug

    Hypertonic Dextrose solution for long night dwell

Treatment groups

194 Participants
are divided into 2 treatment groups
Group A: ICO (icodextrin)Experimental treatment 1 intervention
Group B: CON (control)Other 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

The time of the first episode of peritonitis

The time of the first episode of peritonitis was subtracted from the time of randomization

Time frame
From date of randomization until the date of first documented date of peritonitis, whichever came first, assessed up to 12 months
2

The time of the incidence of anuria

The time of the incidence of anuria was subtracted from the time of randomization

Time frame
From date of randomization until the date of first documented date of anuria, whichever came first, assessed up to 12 months
3

The time of the first incidence of hospitalization

The time of the first incidence of hospitalization was subtracted from the time of randomization

Time frame
From date of randomization until the date of first documented date of hospitalization, whichever came first, assessed up to 12 months
4

The time of technical failure (transferring to HD)

The time of technical failure was subtracted from the time of randomization

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

Baxter Healthcare Corporation

Collaborator

Source ClinicalTrials.gov
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