Sotatercept (ACE-011) in Subjects with End-Stage Kidney Disease

• Research type

  Research Study

• Full title

  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 Erythropoiesis 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

• IRAS ID

  133452

• Contact name

  Debasish Banerjee

• Contact email

  Debasish.Banerjee@stgeorges.nhs.uk

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2012-003788-23

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  13/LO/1798

• Date of REC Opinion

  30 Jan 2014

• REC opinion

  Further Information Favourable Opinion