New dialysis fluid shows promise for kidney patients in Real-World test
NCT ID NCT06492031
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a special dialysis fluid called icodextrin in 439 adults with chronic kidney failure who use peritoneal dialysis at home. The goal was to see if it works better than standard glucose solutions for overnight exchanges and to check for side effects. Researchers tracked how many patients had to switch to a different dialysis method or died. The study was observational, meaning patients got their usual care, and results will help doctors choose the best treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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439 people
The number who actually took part.
- Started
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Jun 2024
- Finished
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Jan 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients in China prescribed icodextrin or glucose PD solutions for continuous ambulatory peritoneal dialysis.
- 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.
Show the full entry requirements Hide 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 for patients enrolled retrospectively in the ICO Group: * Age ≥ 18 years old at first prescription of icodextrin, male or female; * With a definite diagnosis of CRF and on maintenance PD ≥ 3 months; * On CAPD treatment; * Being treated with icodextrin long dwell exchange with an icodextrin prescription ≤ 6 months with essential baseline information(including age, gender, PD vintage, presence of diabetes or not, PET, and assessment of dialysis adequacy); * Voluntarily sign the informed consent form (ICF) and be willing to complete the study visits as required by the investigator (For death cases, exemption of the informed consent will be applied with approval of the ethics committee). Inclusion Criteria for patients enrolled prospectively in the ICO Group: * Age ≥ 18 years old, male or female; * Patients with a definite diagnosis of CRF and on maintenance PD ≥ 3 months; * On CAPD treatment, with planned prescription for icodextrin; * Voluntarily sign the ICF and be willing to complete the study visits as required by the investigator. Exclusion Criteria for the ICO Group: * Those with combined HD within 30 days prior to enrolment; * History of peritonitis within 30 days prior to enrolment or presence of acute or chronic exit site infection or tunnel infection at enrolment; * Participation in another interventional study within 30 days prior to enrolment or concurrently with this study; * Allergy to any components of Icodextrin; * Pregnancy or in lactation; * Any other condition for which the investigator considers the patient to be unsuitable for participation in this study. Inclusion Criteria for the Glucose Group: * Age ≥ 18 years at baseline, male or female; * Those with a definitive diagnosis of CRF prior to baseline and eligible for CAPD treatment with Baxter's glucose PD solutions between July 1, 2018 and December 31, 2018; * On maintenance PD ≥ 3 months; * Essential baseline information (including age, gender, PD vintage, presence of diabetes or not, peritoneal transport status, dialysis adequacy assessment, 24-hour urine volume); * Any prescription of Baxter's glucose PD solutions and medical records of clinical events within 1 year from baseline. Exclusion Criteria for the Glucose Group: * Those with combined HD within 30 days prior to baseline; * History of peritonitis within 30 days prior to baseline or presence of acute or chronic exit site infection or tunnel infection during baseline; * Prescription of non-Baxter PD solutions within 1 month prior to baseline. * Patients enrolled in the ICO group.
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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.
Contacts and locations
Locations
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Beijing Haidian Hospital
Beijing, 100000, China
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Hangzhou Hospital Of Traditional Chinese Medicine
Hangzhou, 310007, China
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Nanjing Drum Tower Hospital
Jiangse, 210008, China
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Ningbo First Hospital
Ningbo, 315000, China
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Renji Hospital Shanghai Jaotong University School of Medicine
Shanghai, 200120, China
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Shanghai General Hospital
Shanghai, 200080, China
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The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, 010000, China
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The First People's Hospital of Kunshan
Jiangse, 215300, China
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The Second Affiliated Hospital of Soochow University
Suzhou, 215004, China
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Wuxi People's Hospital
Jiangse, 214023, China
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Other studies related to the condition(s) this trial covers.
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