Expired Study
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La Mesa, California 91942


Purpose:

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


Study summary:

Part 1: Approximately 8 subjects will be randomized to receive either a single 0.1 mg/kg subcutaneous dose of sotatercept or matching placebo in a 3:1 ratio Part 2: Approximately 8 subjects will be randomized to each of the 3 sequential dose groups (0.3mg/kg or 0.5mg/kg or 0.7 mg/kg) with a 3:1 ratio of sotatercept or placebo (6 subjects in the sotatercept arm and 2 in the placebo arm). A total of 24-36 subjects may be randomized in the 3 dose groups.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.


NCT ID:

NCT01146574


Primary Contact:

Study Director
William T Smith, MD
Celgene Corporation


Backup Contact:

N/A


Location Contact:

La Mesa, California 91942
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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