Evaluating icodextrin and glucose solutions in peritoneal dialysis for chronic renal failure 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

This study is testing whether icodextrin is a better option than glucose for patients on peritoneal dialysis to see how it affects their health and treatment outcomes over a year.

Quick facts

• Study type: Observational
• Enrollment: 889 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vantive Health LLC (Industry-sponsored)
• Locations: 10 sites (Beijing and 9 other locations)
• Trial ID: NCT06492031 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness and safety of icodextrin compared to glucose peritoneal dialysis solutions in patients undergoing continuous ambulatory peritoneal dialysis (CAPD). Patients will be divided into two groups: one receiving icodextrin and the other receiving glucose solutions. Data will be collected both retrospectively and prospectively, with a focus on medical resource utilization and patient outcomes over a 12-month period. The study will include patients who have been on peritoneal dialysis for at least three months and will analyze their treatment responses and overall health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic renal failure who have been on maintenance peritoneal dialysis for at least three months.

Not a fit: Patients who are not on continuous ambulatory peritoneal dialysis or those with acute renal failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into optimizing peritoneal dialysis treatment, potentially improving patient outcomes and quality of life.

How similar studies have performed: Previous studies have shown varying success with different peritoneal dialysis solutions, but this specific comparison of icodextrin and glucose in a structured observational format is relatively novel.

Eligibility criteria

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 index date, male or female;
* Those with a definitive diagnosis of CRF prior to the index date and eligible for CAPD treatment with Baxter's glucose PD solutions between July 1, 2020 and December 31, 2020;
* On maintenance PD ≥ 3 months;
* Essential baseline information(including age, gender, PD vintage, presence of diabetes or not, peritoneal transport status);
* 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 the index date;
* History of peritonitis within 30 days prior to the index date or presence of acute or chronic exit site infection or tunnel infection during the index period;
* Prescription of non-Baxter PD solutions within 1 month prior to the index date.

Where this trial is running

Beijing and 9 other locations

• Beijing Haidian Hospital — Beijing, China (Recruiting)
• Hangzhou Hospital Of Traditional Chinese Medicine — Hangzhou, China (Recruiting)
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, China (Recruiting)
• Nanjing Drum Tower Hospital — Jiangse, China (Recruiting)
• Wuxi People's Hospital — Jiangse, China (Recruiting)
• The First People's Hospital of Kunshan — Jiangse, China (Recruiting)
• Ningbo First Hospital — Ningbo, China (Recruiting)
• Shanghai General Hospital — Shanghai, China (Recruiting)
• Renji Hospital Shanghai Jaotong University School of Medicine — Shanghai, China (Recruiting)
• The Second Affiliated Hospital of Soochow University — Suzhou, China (Recruiting)

Study contacts

• Study coordinator: Global CORP Clinical Trials Disclosure

Conditions Chronic Renal Failure; Continuous ambulatory peritoneal dialysis