Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-03-11 @ 6:42 AM
Study NCT ID:
NCT06433193
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2024-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients
Sponsor:
Nextkidney S.A.
Organization:
Study Overview
Official Title:
Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients
Status:
COMPLETED
Status Verified Date:
2025-03
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 purpose of this study is to demonstrate the safety of dialysate regeneration of the PAK HD sorbent cartridge and therapy efficacy of the PAK HD sorbent therapy compared with conventional hemodialysis.
Detailed Description:
This clinical trial is being conducted to evaluate the biochemical safety of dialysate regeneration with the PAK HD sorbent cartridge in a limited number of patients and treatments. Therapy efficacy of the PAK HD sorbent therapy will be compared to conventional hemodialysis under the same therapy settings. The trial will use only one single PAK HD sorbent therapy per patient, and a total of 3 patients. The PAK HD therapies will be performed in the middle of the week.
Study Oversight
Has Oversight DMC:
True
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?: