Overview

This trial is active, not recruiting.

Conditions anemia, kidney failure, chronic
Treatments sotatercept
Phase phase 2
Sponsor Celgene Corporation
Start date November 2013
End date August 2016
Trial size 49 participants
Trial identifier NCT01999582, 2012-003788-23, ACE-011-REN-002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Intravenous Dose Group 1 starting at 0.1 mg/kg and escalated in Dose Groups 2 (0.2 mg/kg) and Dose Group 3 (0.1, 0.2, 0.3, 0.4 mg/kg, titrated based on titration rules, administered every 14 days)
sotatercept ACE-011
Sotatercept is dosed intravenously every 14 days. The dose a subject receives will depend on the randomization arm and the dose group.
(Experimental)
Subcutaneous Dose Group 1 starting at 0.13 mg/kg and escalated in Dose Groups 2 (0.26 mg/kg) and Dose Group 3 (0.4 to 0.5 mg/kg, titrated based on titration rules, administered every14 days)
sotatercept ACE-011
Sotatercept is dosed subcutaneously every 14 days. The dose a subject receives will depend on the randomization arm and the dose group.

Primary Outcomes

Measure
Pharmacokinetics (Cmax)
time frame: 28 days
Pharmacokinetics (Tmax)
time frame: 28 days
Pharmacokinetics (AUC 28d)
time frame: 28 days
Pharmacokinetics (t1/2,z)
time frame: 211 days
Adverse Event
time frame: 211 days

Secondary Outcomes

Measure
Efficacy
time frame: 113 days
Bone Turnover
time frame: 211 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Males or females ≥ 18 years of age. 2. Subjects on at least 6 hours of hemodialysis per week, for at least 12 weeks before screening 3. Subjects must be on a stable intravenous or subcutaneous dose of Erythropoietin Stimulating Agents (excluding methoxy polyethylene glycol-epoetin beta [Mircera]) to maintain hemoglobin. 4. 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. 4. 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. 6. Able to adhere to the study visit schedule and comply with all protocol requirements. Exclusion Criteria: 1. Non renal causes of anemia 2. Subjects on peritoneal dialysis. 3. Systemic hematological disease 4. Uncontrolled diabetes mellitus (HbA1c (hemoglobin A1c) > 9%) at screening. 5. 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 6. Subjects with heart failure 7. 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). 8. Anticipated or scheduled living donor renal transplant during the course of the study.

Additional Information

Official title A Phase 2 Multicenter, Randomized, Open-Label , Multiple-Dose Study of Intravenous and Subcutaneous Administration of Sotatercept (ACE-011) in Subjects With End-Stage Kidney Disease on Hemodialysis Switched From Erythropoeisis Stimulating Agents With Staggered Dose Group Escalation in Part 1 Followed by a Parallel Group, Active Controlled Study of Selected Dose(s) and Regimen(s) in Part 2: To Evaluate the Pharmacokinetics, Safety, Tolerability, Efficacy, Dosing Regimen, and Pharmacodynamics of Sotatercept
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Celgene Corporation.