Ignite Creation Date:
2024-05-05 @ 10:37 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01146574
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2010-06-16
Brief Title:
A Phase 2a Study To Evaluate The Pharmacokinetics Safety Efficacy Tolerability And Pharmacodynamics of Sotatercept ACE-011 for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase 2a Multi-center Randomized Single Dose Double-blind Placebo-controlled Followed by a Multiple-dose Single-blind Placebo-controlled Dose Escalation Study to Evaluate the Pharmacokinetics Safety Efficacy Tolerability and Pharmacodynamics of Sotatercept ACE-011 for the Correction of Anemia in Subjects With End-stage Renal Disease ESRD on Hemodialysis HD
Status:
COMPLETED
Status Verified Date:
2024-02
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:
This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics safety efficacy tolerability and pharmacodynamics of sotatercept ACE-011
Detailed Description:
Part 1
Approximately 8 subjects will be randomized to receive either a single 01 mgkg subcutaneous dose of sotatercept or matching placebo in a 31 ratio
Part 2
Approximately 8 subjects will be randomized to each of the 3 sequential dose groups 03mgkg or 05mgkg or 07 mgkg with a 31 ratio of sotatercept or placebo 6 subjects in the sotatercept arm and 2 in the placebo arm A total of 24-36 subjects may be randomized in the 3 dose groups
Approximately 8 subjects will be randomized to receive either a single 01 mgkg subcutaneous dose of sotatercept or matching placebo in a 31 ratio
Part 2
Approximately 8 subjects will be randomized to each of the 3 sequential dose groups 03mgkg or 05mgkg or 07 mgkg with a 31 ratio of sotatercept or placebo 6 subjects in the sotatercept arm and 2 in the placebo arm A total of 24-36 subjects may be randomized in the 3 dose groups
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