Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468826
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-06-17
Brief Title:
A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease ESRD
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 1 Open-label Single-dose Study to Evaluate the Pharmacokinetics Safety and Tolerability of Avacopan in Subjects With Normal Renal Function and Subjects With End-Stage Renal Disease ESRD Requiring Hemodialysis
Status:
COMPLETED
Status Verified Date:
2024-10
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 objective of the study is to evaluate the pharmacokinetics PK of avacopan and metabolite M1 after a single dose of avacopan in participants with normal renal function and participants with ESRD requiring hemodialysis HD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None