A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
Public ClinicalTrials.gov record NCT03682536. 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 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).
Study identification
- NCT ID
- NCT03682536
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 363 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
- Jan 2, 2019 (Actual)
- Primary completion
- Mar 31, 2023 (Actual)
- Completion
- Sep 28, 2027 (Estimated)
- Last update posted
- Nov 20, 2024
2019 – 2027
United States locations
- U.S. sites
- 25
- U.S. states
- 16
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 107 | Berkeley | California | 94704 | — |
| Local Institution - 115 | San Diego | California | 92123 | — |
| Local Institution - 101 | Whittier | California | 90603 | — |
| Local Institution - 104 | New Haven | Connecticut | 06520 | — |
| Local Institution - 136 | Washington D.C. | District of Columbia | 20422 | — |
| Local Institution - 119 | Hudson | Florida | 34667 | — |
| Local Institution - 120 | St. Petersburg | Florida | 33705 | — |
| Local Institution - 122 | Tallahassee | Florida | 32308 | — |
| Local Institution - 108 | Tampa | Florida | 33612 | — |
| Local Institution - 118 | West Palm Beach | Florida | 33401 | — |
| Local Institution - 102 | Paducah | Kentucky | 42003 | — |
| Local Institution - 123 | Bethesda | Maryland | 20817 | — |
| Local Institution - 117 | Kansas City | Missouri | 64132 | — |
| Local Institution - 134 | East Brunswick | New Jersey | 08816 | — |
| Local Institution - 113 | Hackensack | New Jersey | 07601 | — |
| Local Institution - 105 | Greenville | North Carolina | 27858-4354 | — |
| Local Institution - 131 | Portland | Oregon | 97213 | — |
| Univ of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | — |
| Local Institution - 111 | Rock Hill | South Carolina | 29732 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203-1625 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Local Institution - 109 | Houston | Texas | 77030 | — |
| Local Institution - 114 | Salt Lake City | Utah | 84106 | — |
| Local Institution - 132 | Charlottesville | Virginia | 22903 | — |
| Local Institution - 127 | Chesapeake | Virginia | 23320 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 201 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03682536, 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 Nov 20, 2024 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03682536 live on ClinicalTrials.gov.