NCT06492031Completed
Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
Effectiveness and Safety of Icodextrin Peritoneal Dialysis Solution (Extraneal®) for Long Dwell Exchange in Peritoneal Dialysis in Patients With Chronic Renal Failure: a Multicenter, Ambispective Cohort, Observational, Real-world Study
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the effectiveness and safety of icodextrin and glucose peritoneal dialysis (PD) solutions for the long dwell exchange in PD patients with continuous ambulatory peritoneal dialysis (CAPD), and to describe medical resource utilization in patients with PD on icodextrin.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 439 (actual)
- First submitted
- 25 Jun 2024
- Start date
- 28 Jun 2024
- Primary completion date
- 27 Jan 2026
- Lead sponsor
- Vantive Health LLC
- Diseases
- Chronic kidney disease
- NCT number
- NCT06492031
What you commit to
- Study type: Observational
- Participants enrolled: 439
- From 28 Jun 2024 to the primary completion date, 27 Jan 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- 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.
Other illness
- Allergy to any components of Icodextrin;
- Any other condition for which the investigator considers the patient to be unsuitable for participation in this study.
Other
- Pregnancy or in lactation;
- Patients enrolled in the ICO group.
Who the study is looking for
- 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).
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Haidian Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Hangzhou Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Affiliated Hospital of Inner Mongolia Medical University Coordinator of this site? Confirm its status | Hohhot | China | Unknown status |
| The First People's Hospital of Kunshan Coordinator of this site? Confirm its status | Jiangse | China | Unknown status |
| Nanjing Drum Tower Hospital Coordinator of this site? Confirm its status | Jiangse | China | Unknown status |
| Wuxi People's Hospital Coordinator of this site? Confirm its status | Jiangse | China | Unknown status |
| Ningbo First Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Renji Hospital Shanghai Jaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.