At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
Sotatercept +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Sotatercept for Anemia and Kidney Failure, Chronic. Completed, enrolled 50 participants across 23 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Kidney Failure, Chronic
CountriesBelgium, Germany, Portugal, Spain, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedDec 2013
Primary CompletionAug 2016
TodayJul 2026
First PostedDec 3, 2013
Enrollment StartNov 30, 2013
Primary CompletionAug 31, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.6 years ago
Interventions
Sotaterceptbiological
Sotatercept is dosed intravenously every 14 days. The dose a subject receives will depend on the randomization arm and the dose group.
Sotaterceptbiological
Sotatercept is dosed subcutaneously every 14 days. The dose a subject receives will depend on the randomization arm and the dose group.