Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients

Launched by VANTIVE HEALTH LLC · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of two different solutions, icodextrin and glucose, in a type of treatment called peritoneal dialysis (PD) for patients with chronic renal failure (CRF). The main goal is to find out how effective and safe these solutions are for patients who are on continuous ambulatory peritoneal dialysis (CAPD). Researchers want to understand how often patients use medical resources while being treated with icodextrin.

To participate in the study, individuals must be at least 18 years old, have a confirmed diagnosis of chronic renal failure, and have been on PD for at least three months. They should also be currently using CAPD and agree to take part in the study visits. Participants will be monitored to see how well the treatments work and any side effects they may experience. It's important to note that some individuals may not be eligible, including those who have had recent infections or are pregnant. Overall, this study aims to gather valuable information that could improve treatment options for patients needing peritoneal dialysis.

Gender

ALL

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.