Clinical trial

A Phase 2a, Multi-center, Randomized, Single Dose, Double-blind, Placebo-controlled Followed by a Multiple-dose, Single-blind, Placebo-controlled, Dose Escalation 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 (ESRD) on Hemodialysis (HD).

Name

ACE-011-REN-001

Description

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

Trial arms

Trial start

2010-06-30

Estimated PCD

2016-03-07

Trial end

2016-03-07

Status

Completed

Phase

Early phase I

Treatment

Sotatercept

Part 1: Sotatercept single dose 0.1mg/kg subcutaneous Part 2: Sotatercept starting dose groups of 0.3mg/kg, 0.5mg/kg or 0.7 mg/kg in a sequential design, dosed subcutaneously every 28 days for up to 8 doses

Arms:

0.1mg/kg Sotatercept, 0.3mg/kg Sotatercept, 0.5mg/kg Sotatercept, 0.7mg/kg Sotatercept

Other names:

ACE-011

Placebo

Arms:

Placebo

Size

Primary endpoint

Observed Maximum Concentration (Cmax)

From first dose up to Day 28

Time to Maximum Concentration (Tmax)

From first dose up to Day 28

Area Under Curve (AUC)-28 Days

From first dose up to Day 28

AUCinf: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity

From first dose up to Day 28

Apparent Total Clearance (CL/F)

From first dose up to Day 28

Apparent Volume of Distribution Based on Terminal Phase (Vz/F)

From first dose up to Day 28

Terminal Half-Life (t1/2,z)

Days 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 85 and 113

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 \< 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. * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}

Updated at

2024-03-01

1 organization

2 products

1 indication

Organization

Product

Indication

Product