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.

Completed · Phase 2 · Has a placebo group

Conditions studied: Anemia

In brief

This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)

Key facts

Study ID

NCT01146574

Run by

Celgene

People needed

50

Starts

2010-06-30

Expected to finish

2016-03-07

Last updated by the study team

2024-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females ≥18 years of age.
• Subjects on hemodialysis for at least 12 weeks before screening
• Subjects on a stable dose of Erythrocyte Stimulating Agents product to maintain Hemoglobin (Hb) for at least 6 weeks prior to screening.
• 3 consecutive pre-dialysis Hb concentrations with a mean ≥10 to ≤ 12 g/dL (≥100 to ≤120 g/L) at screening and one pre-dialysis Hb concentration ≥8 to < 10 g/dL (≥ 80 to < 100 g/L) before randomization.
• Adequate iron status defined as serum transferrin saturation ≥ 20% before randomization.

You may not qualify if…

• Non renal causes of anemia.
• Subjects on peritoneal dialysis.
• Systemic hematological disease
• High sensitivity C-reactive protein >50mg/L at screening.
• Alanine transaminase (ALT) or aspartate transaminase (AST) laboratory values > 2 times the upper limit of normal (ULN) at screening.
• Uncontrolled diabetes mellitus (HbA1c > 9) at screening.
• Uncontrolled hypertension.
• Red Blood Count (RBC) transfusions within 8 weeks prior to screening.
• Active serious infection or history of recurrent serious infection likely to recur during the study
• History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product or to the iron products needed to normalize iron levels for subjects.
• Subjects that received treatment with another investigational drug or device within 28 days prior to Day 1
• Pregnant or lactating females.

Where it is running

• North American Research Institute — Azusa, California, United States
• West Glendale Dialysis — Glendale, California, United States
• California Institute of Renal Research — La Mesa, California, United States
• Academic Medical Center — Los Angeles, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• Nephrology Specialist Medical Group — Orange, California, United States
• Pines Clinical Research Inc. — Pembroke Pines, Florida, United States
• University of Kentucky — Lexington, Kentucky, United States
• Fresenius Medical Care North America MI — Kalamazoo, Michigan, United States
• DaVita Clinical Research — Minneapolis, Minnesota, United States
• Nephrology and Hypertension Associates, LTD — Tupelo, Mississippi, United States
• St. Louis University Medical Center — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Kidney Specialists of Southen Nevada — Las Vegas, Nevada, United States
• Brookview Hill Research Associates, LLC — Winston-Salem, North Carolina, United States
• MetroHealth Medical Systems — Cleveland, Ohio, United States
• Northeast Clinical Research Center — Bethlehem, Pennsylvania, United States
• Nephrology Associates, PC — Nashville, Tennessee, United States
• Corva Kidney Center Webster — Houston, Texas, United States
• Beechnut Dialysis Center — Houston, Texas, United States
• Miracle Medical Clinic — Houston, Texas, United States
• Gessner Dialysis Center — Houston, Texas, United States
• Tyler Nephrology Associates, PC — Tyler, Texas, United States
• University of Virginia at University Ave. — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.