Status:
COMPLETED
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.
Lead Sponsor:
Celgene
Collaborating Sponsors:
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01146574
Start Date
June 30 2010
End Date
March 7 2016
Last Update
March 1 2024
Active Locations (24)
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1
North American Research Institute
Azusa, California, United States, 91702-3439
2
West Glendale Dialysis
Glendale, California, United States, 91205
3
California Institute of Renal Research
La Mesa, California, United States, 91942
4
Academic Medical Center
Los Angeles, California, United States, 90022