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.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Celgene
With
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | 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.
