Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492031
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-25
Brief Title:
Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
Sponsor:
Baxter Healthcare Corporation
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
oSCAR
Brief 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
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 ie within 6 months before the launch of the study site data will be collected from baseline ie 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 ie 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
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 ie within 6 months before the launch of the study site data will be collected from baseline ie 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None