Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients (oSCAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Renal Failure
• Intervention / Treatment: Drug: Icodextrin Peritoneal Dialysis Solution; Drug: Glucose Peritoneal Dialysis Solution

Detailed Description

Patients will be divided into icodextrin dialysate group (ICO group) and glucose dialysate group (glucose group).

ICO group: Patient data will be collected retrospectively and prospectively. Patients currently prescribed icodextrin will be recruited and enrolled. Data for these patients will included both retrospective historical data collection as well as a prospective collection of additional data. Within the relative look-back period (i.e., within 6 months before the launch of the study site), data will be collected from baseline (i.e., the most recent medical records prior to the first prescription of icodextrin) up to signing of the ICF. After providing informed consent, patient data will be prospectively collected for 12 months.

Additionally, any patients who are first prescribed icodextrin therapy after the launch of the study site will also be recruited and enrolled prospectively and data will be collected up to 12 months from enrollment for this group. For these patients, baseline will be defined as the most recent medical record from the time of signing the ICF to the first prescription of icodextrin.

Glucose group: Patient data will be collected retrospectively from CAPD patients followed up in the peritoneal dialysis center from July 1, 2018, to December 31, 2018. Retrospective data will be collected up to 12 months from baseline (i.e., the most recent peritoneal equilibration test date before December 31, 2018, in the peritoneal dialysis center).

The effectiveness and safety between the 2 groups will be analyzed.

• Study Type: Observational
• Enrollment (Actual): 439

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100000
    • Beijing Haidian Hospital
  • Hangzhou, China, 310007
    • Hangzhou Hospital of Traditional Chinese Medicine
  • Hohhot, China, 010000
    • The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangse, China, 210008
    • Nanjing Drum Tower Hospital
  • Jiangse, China, 214023
    • Wuxi People's Hospital
  • Jiangse, China, 215300
    • The First People's Hospital of Kunshan
  • Ningbo, China, 315000
    • Ningbo First Hospital
  • Shanghai, China, 200080
    • Shanghai General Hospital
  • Shanghai, China, 200120
    • Renji Hospital Shanghai Jaotong University School of Medicine
  • Suzhou, China, 215004
    • The Second Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in China prescribed icodextrin or glucose PD solutions for continuous ambulatory peritoneal dialysis.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Icodextrin (ICO) Group; Icodextrin is only intended for intraperitoneal administration and is recommended for long dwell during CAPD (i.e., recommended dwell time from 8-16 hours). Administration will be done at a rate that is comfortable for the patient, typically within 10-20 minutes.	Drug: Icodextrin Peritoneal Dialysis Solution; The treatment modality, treatment frequency, treatment dose, duration of dwell, and length of treatment, as determined and supervised by a prescribing physician experienced in treating ESRD with PD.; Other Names: Extraneal
Glucose Group; During CAPD, 2L of dialysis fluid is instilled into the peritoneal cavity and allowed to dwell for a certain period. The dwell time typically ranges from 4 to 8 hours during the day and 8 to 12 hours at night. This process is repeated 3 to 4 times a day, for 6 to 7 days a week. The frequency of solution exchanges may vary for each individual to achieve desired biochemical and solution control. Most solution exchanges utilize a 1.5% or 2.5% glucose dialysis solution. If more solution removal is required, a 4.25% glucose peritoneal dialysis solution can be used. Regular measurement of the patient's weight can be used to guide the setting of ultrafiltration volume.	Drug: Glucose Peritoneal Dialysis Solution; The treatment modality, number of daily dialysate exchanges, dialysate concentration, exchange dosage of dialysate, duration of dwell, and length of treatment for PD patients as determined by the clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the incidence of a composite endpoint for technique failure and death	Technique failure is defined as: Treatment transferred from PD to HD/PHD > 30 days; or; PHD, defined as adding HD treatment at least once every 2 weeks in 30 days during PD and requiring long-term combined HD as determined by the investigator. Death is specified as deaths during PD or deaths within 30 days with treatment from PD to HD/PHD	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the proportion of patients with technique failure	Number and proportion of patients with technique failure	12 months
Comparison of the incidence of cardiovascular events	Cardiovascular events include acute myocardial infarction, sudden severe arrhythmia ( a trial fibrillation and arrhythmia requiring hospitalization or medication), hospitalization for heart failure, stroke, and cardiovascular death.	12 months
Comparison of the incidence of the changes in ejection fraction	Change of the echocardiographic values from baseline: left ventricular ejection fraction fraction (LVEF）	12 months
Comparison of all-cause deaths	All-cause deaths refer to the total number of deaths from any cause within the study timeframe	12 months
Comparison of medical resource utilization in terms of hospitalizations	Excluding hospitalizations due to medicare payments or other non-medical issues. For ICO group only	12 months
Comparison of annual exchange dosage of ICO	For ICO group only	12 months

Collaborators and Investigators

• Sponsor: Vantive Health LLC
• Collaborators: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2024
• Primary Completion (Actual): January 27, 2026
• Study Completion (Actual): January 27, 2026

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Continuous ambulatory peritoneal dialysis
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Carbohydrates; Polymers; Macromolecular Substances; Polysaccharides; Glucans; Biopolymers; Icodextrin
• Other Study ID Numbers: BXU599284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Sponsor is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, the Sponsor will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP).
• IPD Sharing Time Frame: Upon approval of a legitimate research request.
• IPD Sharing Access Criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If the Sponsor agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of the Sponsor prior to the release of any data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP