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

Baxter

Status: Enrolling

Conditions: Chronic Renal Failure

Treatments: Drug: Glucose Peritoneal Dialysis Solution; Drug: Icodextrin Peritoneal Dialysis Solution

Study type: Observational

Funder types: Industry

Identifiers

NCT06492031

BXU599284

Details and patient eligibility

About

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.

Full 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. Retrospective data will be collected up to 12 months from baseline (i.e., the most recent medical record before the index date, whereby the index date is defined as the date of the first prescription of glucose PD solutions for long dwell exchange between July 1, 2020, and December 31, 2020).

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

Enrollment: 889 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

889 participants in 2 patient groups

Icodextrin (ICO) Group

Description:

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.

Treatment:

Drug: Icodextrin Peritoneal Dialysis Solution

Glucose Group

Description:

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.

Treatment:

Drug: Glucose Peritoneal Dialysis Solution