Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-28 @ 7:33 AM
Study NCT ID:
NCT04689932
Status:
COMPLETED
Last Update Posted:
2022-02-28
First Post:
2020-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Sponsor:
Rockwell Medical Technologies, Inc.
Organization:
Study Overview
Official Title:
Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Status:
COMPLETED
Status Verified Date:
2022-02
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 main purpose of this study is to evaluate the delivery of Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood lines.
Detailed Description:
This is a single center, multi dose, open label study assessing the delivery of Triferic AVNU administered intravenously to adult patients (\> or equal to 18 years of age) using the Freedom Pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood lines.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: