drugset / Trial / NCT01999582
A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis
RandomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2013-11-30
- Primary completion
- 2016-08-31
- Completion
- 2016-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotatercept | Protein / enzyme biologic | 0.1 mg/kg | Intravenous |
| Subject | Sotatercept | Protein / enzyme biologic | 0.13 mg/kg | Intravenous |
| Subject | Sotatercept | Protein / enzyme biologic | 0.2 mg/kg | Intravenous |
| Subject | Sotatercept | Protein / enzyme biologic | 0.26 mg/kg | Intravenous |
| Subject | Sotatercept | Protein / enzyme biologic | 0.3 mg/kg | Intravenous |
| Subject | Sotatercept | Protein / enzyme biologic | 0.4 mg/kg | Intravenous |
| Subject | Sotatercept | Protein / enzyme biologic | 0.5 mg/kg | Intravenous |