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New dialysis fluid shows promise for kidney patients in Real-World test

NCT ID NCT06492031

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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.

Participants

439 people

The number who actually took part.

Started

Jun 2024

Finished

Jan 2026

Lead sponsor

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

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 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

  • Beijing Haidian Hospital

    Beijing, 100000, China

  • Hangzhou Hospital Of Traditional Chinese Medicine

    Hangzhou, 310007, China

  • Nanjing Drum Tower Hospital

    Jiangse, 210008, China

  • Ningbo First Hospital

    Ningbo, 315000, China

  • Renji Hospital Shanghai Jaotong University School of Medicine

    Shanghai, 200120, China

  • Shanghai General Hospital

    Shanghai, 200080, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, 010000, China

  • The First People's Hospital of Kunshan

    Jiangse, 215300, China

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004, China

  • Wuxi People's Hospital

    Jiangse, 214023, China

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