Phase 2 Completed N=50 Randomized Treatment

A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis

Anemia · Kidney Failure, Chronic

Source: ClinicalTrials.gov NCT01999582 ↗

Enrolled (actual)

Serious AEs

26.0%

Results posted

Jun 2024

Primary outcomePrimary: Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days) — 15204.31; 11269.14; 28647.03; 10327.98 day*ng/mL

Summary

To determine the optimal route of administration, dose level, and safety of intravenous and subcutaneous dosing of sotatercept for maintaining hemoglobin levels in subjects who are on hemodialysis.

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days)	15204.31; 11269.14; 28647.03; 10327.98; 15886.83; 21982.9	—
PRIMARY Area Under the Serum Concentration- Time Curve Over From Day 1 to Day 28 (AUC28d)	38361.5; 41500.36; 94106.54; 36065.09; 33173.4; 60497.8	—
PRIMARY Maximum Observed Serum Concentration Obtained From the First Dose (Cmax14d)	2567.6; 1024.27; 4623.61; 963.05; 3155.53; 1993.58	—
PRIMARY Maximum Observed Serum Concentration (Cmax28d) Obtained From the Combined First 2 Doses	3557.93; 3868.83; 8613.67; 1967.55; 3501.54; 3161.6	—
PRIMARY Time to Reach Maximum Observed Serum Concentration (Tmax)	14.09; 21.01; 14.02; 18.51; 0.1688; 21.06	—
PRIMARY Estimate of Terminal Elimination Half-Life in Serum at Final Dose Only (t1/2)	17.6; 25.87; 21.76; 21.03; 22.46; 20.39	—
PRIMARY Lambda (ʎz): Apparent Terminal Rate Constant (at Final Dose Only)	0.0414; 0.0282; 0.0328; 0.0346; 0.0326; 0.0355	—
SECONDARY Percentage of Participants With Mean Hemoglobin ≥ 100 g/L to ≤ 120 g/L Without Rescue Medication	42.9; 42.9; 11.1; 33.3; 25; 50	—
SECONDARY Change From Baseline in Mean Hemoglobin Concentration for Visit 14 to 17 (All Participants Regardless of Rescue)	-6.9; -2.7; -2.1; -0.8; -9.9; -6.4	—
SECONDARY Change From Baseline in Mean Hemoglobin Concentration for Visit 14 to 17 (Participants Not Rescued Prior to Day 115)	-7; -3.6; -0.3; 0.5; -13; -1	—
SECONDARY Number of Participants With Adverse Events (AEs)	7; 3; 9; 6; 10; 6	—

Eligibility Criteria

Inclusion Criteria

Males or females ≥ 18 years of age.
Subjects on at least 6 hours of hemodialysis per week, for at least 12 weeks before screening
Subjects must be on a stable intravenous or subcutaneous dose of Erythropoietin Stimulating Agents (excluding methoxy polyethylene glycol-epoetin beta [Mircera]) to maintain hemoglobin.
A mean predialysis hemoglobin concentration ≥ 10 g/dL (grams per deciliter) to ≤ 12 g/dL (≥ 100 g/L (grams per liter) to ≤ 120 g/L) obtained from three consecutive days.
A Body Mass Index value ≥ 18.5 kg/m2 (kilograms per m2) at screening. 5. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
Able to adhere to the study visit schedule and comply with all protocol requirements.

Exclusion Criteria

Non renal causes of anemia
Subjects on peritoneal dialysis.
Systemic hematological disease
Uncontrolled diabetes mellitus (HbA1c (hemoglobin A1c) > 9%) at screening.
Uncontrolled hypertension defined as mean of home systolic blood pressure > 160 mm Hg (millimeter of mercury) or mean of home diastolic blood pressure > 90 mm Hg calculated once during the screening period prior to randomization
Subjects with heart failure
History of malignancy (except excised and cured non-melanoma skin cancer, or cervical carcinoma in situ that was surgically ablated more than 5 years ago).
Anticipated or scheduled living donor renal transplant during the course of the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01999582). 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.