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

Conditions	Phase	Intervention Type
Kidney Failure, Chronic Kidney Diseases Anemia	Phase 2	Biological Placebo Biological Sotatercept

View trial NCT01146574 on www.clinicaltrials.gov

Contacts

Please use the information below to contact the trial coordinators.

Lisa Serme, BS, MA

732-652-6307

Lserme@Celgene.com Hem Nalini Singh, DVM, MS

732-652-6473

hsingh@celgene.com

Eligibility

Ages Eligible for Study: 18 years and up
Genders Eligible for Study: Both

Keywords

End-Stage Renal Disease, Anemia, Hemodialysis, Renal Anemia, and ESRD

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.

- 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.

Detailed Description

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146574

Overall Contact

Hem Nalini Singh, DVM, MS