drugset / Trial / NCT01146574
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.
Phase 2
Completed
50 enrolled
Celgene Corporation
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA · collab
RandomizedSingle-groupSingle-blindTreatment
Summary
This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)
Timeline
- Start
- 2010-06-30
- Primary completion
- 2016-03-07
- Completion
- 2016-03-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotatercept | Protein / enzyme biologic | 0.1 mg/kg | Subcutaneous |
| Subject | Sotatercept | Protein / enzyme biologic | 0.3 mg/kg | Subcutaneous |
| Subject | Sotatercept | Protein / enzyme biologic | 0.5 mg/kg | Subcutaneous |
| Subject | Sotatercept | Protein / enzyme biologic | 0.7 mg/kg | Subcutaneous |