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New dialysis solution may delay need for full treatment in kidney patients

NCT ID NCT05721404

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This trial investigates whether using icodextrin, a special dialysis solution, can help people on peritoneal dialysis (a type of home dialysis for kidney failure) stay on a lower-dose regimen for longer. Participants are randomly assigned to receive either icodextrin or a standard sugar-based solution when they show signs of fluid overload. The goal is to see if icodextrin delays the need to switch to full-dose dialysis and improves outcomes like infection rates and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Icodextrin peritoneal dialysis solution
What this could lead to
If it works, this could help people on peritoneal dialysis maintain a lower treatment burden for longer, with less glucose exposure and potentially fewer complications.
What could go wrong
This is a single-center Phase 4 trial with 194 participants, so results may not apply broadly. The benefit may be modest, and icodextrin can cause side effects like skin reactions or sterile peritonitis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 194 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510080, China

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