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.
Public ClinicalTrials.gov record NCT01146574. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)
Study identification
- NCT ID
- NCT01146574
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2010 (Actual)
- Primary completion
- Mar 7, 2016 (Actual)
- Completion
- Mar 7, 2016 (Actual)
- Last update posted
- Mar 1, 2024
2010 – 2016
United States locations
- U.S. sites
- 24
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North American Research Institute | Azusa | California | 91702-3439 | — |
| West Glendale Dialysis | Glendale | California | 91205 | — |
| California Institute of Renal Research | La Mesa | California | 91942 | — |
| Academic Medical Center | Los Angeles | California | 90022 | — |
| Academic Medical Research Institute | Los Angeles | California | 90022 | — |
| Nephrology Specialist Medical Group | Orange | California | 92868 | — |
| Pines Clinical Research Inc. | Pembroke Pines | Florida | 33028 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Fresenius Medical Care North America MI | Kalamazoo | Michigan | 49007 | — |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | — |
| Nephrology and Hypertension Associates, LTD | Tupelo | Mississippi | 38801 | — |
| St. Louis University Medical Center | St Louis | Missouri | 63110 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Kidney Specialists of Southen Nevada | Las Vegas | Nevada | 89106 | — |
| Brookview Hill Research Associates, LLC | Winston-Salem | North Carolina | 27103 | — |
| MetroHealth Medical Systems | Cleveland | Ohio | 44109 | — |
| Northeast Clinical Research Center | Bethlehem | Pennsylvania | 18017 | — |
| Nephrology Associates, PC | Nashville | Tennessee | 37205 | — |
| Corva Kidney Center Webster | Houston | Texas | 77003 | — |
| Beechnut Dialysis Center | Houston | Texas | 77036 | — |
| Miracle Medical Clinic | Houston | Texas | 77055 | — |
| Gessner Dialysis Center | Houston | Texas | 77074 | — |
| Tyler Nephrology Associates, PC | Tyler | Texas | 75702 | — |
| University of Virginia at University Ave. | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01146574, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 1, 2024 · Synced Nov 2, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01146574 live on ClinicalTrials.gov.