Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433193
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-05-22
Brief Title:
Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients
Sponsor:
Nextkidney SA
Organization:
Nextkidney SA
Study Overview
Official Title:
Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients
Status:
COMPLETED
Status Verified Date:
2024-05
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:
None
Brief Summary:
The primary aim of this early feasibility clinical trial is to assess the biochemical safety of dialysate regeneration with the optimised PAK HDsorbent cartridge in a limited number n3 of participants and treatments one therapy per subject As a secondary aim we will assessthe therapy efficacy of the PAK HD sorbent therapy in short-daily hemodialysis SDHD and compare it to that of conventional CHD underthe same therapy settings
Following up from the preceding FIH trial this continuation aims at demonstrating that the optimised PAK HD sorbent system has overcome previous problems of increased dialysate acidity and provides improved control over the patients acid-base balance
Following up from the preceding FIH trial this continuation aims at demonstrating that the optimised PAK HD sorbent system has overcome previous problems of increased dialysate acidity and provides improved control over the patients acid-base balance
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None