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)

Trial Profile

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)

Completed
Phase of Trial: Phase II

Latest Information Update: 10 Mar 2017

At a glance

  • Drugs Sotatercept (Primary)
  • Indications Anaemia
  • Focus Pharmacokinetics
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 17 Mar 2016 Status changed from recruiting to completed, according to ClinicalTrials.gov record.
    • 25 Feb 2016 According to Acceleron media release, preliminary data from this study were presented at the American Society of Nephrology Kidney Week in October 2015.
    • 02 Oct 2015 According to Acceleron media release, interim clinical data will be presented at the American Society of Nephrology (ASN) Kidney Week 2015.
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