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 Dose(s) and Regimen(s) in Part 2: To Evaluate the Pharmacokinetics, Safety, Tolerability, Efficacy, Dosing Regimen, and Pharmacodynamics of Sotatercept

Trial Profile

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 Dose(s) and Regimen(s) in Part 2: To Evaluate the Pharmacokinetics, Safety, Tolerability, Efficacy, Dosing Regimen, and Pharmacodynamics of Sotatercept

Completed
Phase of Trial: Phase II

Latest Information Update: 20 Feb 2017

At a glance

  • Drugs Sotatercept (Primary) ; Sotatercept (Primary)
  • Indications Renal failure
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 14 Feb 2017 Status changed from active, no longer recruiting to completed.
    • 14 Jan 2017 This trial has been completed in Portugal (end date:2016-08-23) as per European Clinical Trials Database record.
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