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. | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

March 7, 2016

Study Completion Date

March 7, 2016

Conditions

Anemia

Interventions

BIOLOGICAL

Sotatercept

Part 1: Sotatercept single dose 0.1mg/kg subcutaneous Part 2: Sotatercept starting dose groups of 0.3mg/kg, 0.5mg/kg or 0.7 mg/kg in a sequential design, dosed subcutaneously every 28 days for up to 8 doses

BIOLOGICAL

Placebo

Trial Locations (24)

18017

Northeast Clinical Research Center, Bethlehem

22908

University of Virginia at University Ave., Charlottesville

27103

Brookview Hill Research Associates, LLC, Winston-Salem

33028

Pines Clinical Research Inc., Pembroke Pines

37205

Nephrology Associates, PC, Nashville

38801

Nephrology and Hypertension Associates, LTD, Tupelo

40536

University of Kentucky, Lexington

44109

MetroHealth Medical Systems, Cleveland

49007

Fresenius Medical Care North America MI, Kalamazoo

55404

DaVita Clinical Research, Minneapolis

63110

St. Louis University Medical Center, St Louis

Washington University School of Medicine, St Louis

75702

Tyler Nephrology Associates, PC, Tyler

77003

Corva Kidney Center Webster, Houston

77036

Beechnut Dialysis Center, Houston

77055

Miracle Medical Clinic, Houston

77074

Gessner Dialysis Center, Houston

89106

Kidney Specialists of Southen Nevada, Las Vegas

90022

Academic Medical Center, Los Angeles

Academic Medical Research Institute, Los Angeles

91205

West Glendale Dialysis, Glendale

91942

California Institute of Renal Research, La Mesa

92868

Nephrology Specialist Medical Group, Orange

91702-3439

North American Research Institute, Azusa