New dialysis solution may delay need for full treatment in kidney patients
NCT ID NCT05721404
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 194 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The First Affiliated Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510080, China
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