RecruitingNCT06492031

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

Sponsor

Vantive Health LLC

Enrollment

889 participants

Start Date

Jun 28, 2024

Study Type

OBSERVATIONAL

Conditions

Chronic Renal Failure

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria14

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 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 Criteria9

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.
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.

Interventions

DRUGIcodextrin 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.

DRUGGlucose 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.