Ignite Creation Date:
2024-05-06 @ 2:13 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01999582
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2013-11-26
Brief Title:
A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept ACE-011 in Patients With End-Stage Kidney Disease on Hemodialysis
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Open-Label Multiple-Dose Study of Intravenous and Subcutaneous Administration of Sotatercept ACE-011 in Subjects With End-Stage Kidney Disease on Hemodialysis Switched From Erythropoeisis Stimulating Agents With Staggered Dose Group Escalation in Part 1 Followed by a Parallel Group Active Controlled Study of Selected Doses and Regimens in Part 2 To Evaluate the Pharmacokinetics Safety Tolerability Efficacy Dosing Regimen and Pharmacodynamics of Sotatercept
Status:
COMPLETED
Status Verified Date:
2024-01
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:
To determine the optimal route of administration dose level and safety of intravenous and subcutaneous dosing of sotatercept for maintaining hemoglobin levels in subjects who are on hemodialysis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-003788-23 | EUDRACT_NUMBER | None | None |