Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520826
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Vafseo Outcomes In-Center Experience
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety of Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects Vafseo Outcomes In-Center Experience
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VOICE
Brief Summary:
This trial is an investigator-initiated multi-center randomized 11 open-label active-controlled pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease ESKD This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing
Detailed Description:
None
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