Phase 2
Completed N=50
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.
Source: ClinicalTrials.gov NCT01146574 ↗Enrolled (actual)
50
Serious AEs
30.0%
Results posted
Mar 2024
Primary outcomePrimary: Observed Maximum Concentration (Cmax) — 1.022; 2.40; 3.66; 3.97 ug/mL
Summary
This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observed Maximum Concentration (Cmax) |
1.022; 2.40; 3.66; 3.97; 7.71 | — |
| PRIMARY Time to Maximum Concentration (Tmax) |
6; 7; 8; 7; 5 | — |
| PRIMARY Area Under Curve (AUC)-28 Days |
20.6; 50.64; 78.03; 87.51; 126.96 | — |
| PRIMARY AUCinf: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity |
35.8 | — |
| PRIMARY Apparent Total Clearance (CL/F) |
3.22; 0.255; 0.261; 0.532; 0.298 | — |
| PRIMARY Apparent Volume of Distribution Based on Terminal Phase (Vz/F) |
98 | — |
| PRIMARY Terminal Half-Life (t1/2,z) |
21.1; 24.3; 32.1; 22.2; 19.6 | — |
| SECONDARY The Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
1; 6; 7; 8; 6; 8 | — |
| SECONDARY Number of Participants With Hemoglobin > 12g/dL |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Proportion of Participants With Rise in Hemoglobin > 2 g/dL During 4 Week Period |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Blood Pressure Changes From Baseline |
151.0; 142.8; 129.4; 145.9; 141.4; 139.9 | — |
| SECONDARY Changes in Follicle Stimulating Hormone (FSH) |
23.5; 36.9; 17.1; 51.8; 17.5; 37.4 | — |
| SECONDARY Number of Participants With Hemoglobin > 10g/dL |
3; 3; 5; 7; 2 | — |
| SECONDARY Number of Participants With Change From Baseline Hemoglobin ≥ 1g/dL |
2; 3; 4; 7; 2 | — |
| SECONDARY Number of Participants With Hemoglobin > 10g/dL and Change From Baseline Hemoglobin ≥ 1g/dL |
2; 2; 4; 6; 2 | — |
| SECONDARY Length of Time to Rescue Therapy |
44.8; 69.8; 47.4; 100.4; 117.5 | — |
| SECONDARY Change From Baseline in Hemoglobin Values |
-3.3; -6.9; -2.9; 0.8; 1.0; -0.9 | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT01146574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.