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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.
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Inclusion and exclusion criteria
Inclusion Criteria for patients enrolled retrospectively in the ICO Group:
Inclusion Criteria for patients enrolled prospectively in the ICO Group:
Exclusion Criteria for the ICO Group:
Inclusion Criteria for the Glucose Group:
Exclusion Criteria for the Glucose Group:
889 participants in 2 patient groups
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Baxter CORP Clinical Trials Disclosure
Data sourced from clinicaltrials.gov
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