ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
Public ClinicalTrials.gov record NCT05949684. 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) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The "ELEMENT-MDS" Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).
Study identification
- NCT ID
- NCT05949684
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 402 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
- Oct 23, 2023
- Primary completion
- Mar 23, 2028
- Completion
- May 29, 2031
- Last update posted
- Jun 29, 2026
2023 – 2031
United States locations
- U.S. sites
- 33
- U.S. states
- 16
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 0070 | Clovis | California | 93611 | — |
| Local Institution - 0179 | Fountain Valley | California | 92708 | — |
| Local Institution - 0211 | Los Alamitos | California | 90720 | — |
| Local Institution - 0258 | Los Angeles | California | 90095 | — |
| Local Institution - 0247 | Orange | California | 92868 | — |
| Local Institution - 0209 | Oxnard | California | 93030 | — |
| Local Institution - 0183 | Walnut Creek | California | 94598 | — |
| Local Institution - 0227 | Hartford | Connecticut | 06102 | — |
| Local Institution - 0173 | New Haven | Connecticut | 06510 | — |
| Halifax Health Medical Center | Daytona Beach | Florida | 32114 | — |
| Local Institution - 0202 | Fort Myers | Florida | 33901 | — |
| Local Institution - 0180 | Jacksonville | Florida | 32207 | — |
| Local Institution - 0224 | Margate | Florida | 33063 | — |
| Local Institution - 0163 | Plantation | Florida | 33322 | — |
| Local Institution - 0201 | St. Petersburg | Florida | 33705 | — |
| Local Institution - 0238 | Tamarac | Florida | 33321 | — |
| Local Institution - 0106 | Tampa | Florida | 33612 | — |
| Local Institution - 0240 | Honolulu | Hawaii | 96813 | — |
| Local Institution - 0272 | Chicago | Illinois | 60611 | — |
| Local Institution - 0184 | Skokie | Illinois | 60077 | — |
| Local Institution - 0270 | Dyer | Indiana | 46311 | — |
| Local Institution - 0191 | Baton Rouge | Louisiana | 70808 | — |
| Local Institution - 0044 | Covington | Louisiana | 70433 | — |
| Local Institution - 0007 | Bethesda | Maryland | 20817 | — |
| Local Institution - 0222 | Saint Louis Park | Minnesota | 55426 | — |
| Local Institution - 0128 | Hattiesburg | Mississippi | 39401 | — |
| Local Institution - 0212 | Hackensack | New Jersey | 07601 | — |
| Local Institution - 0206 | Columbus | Ohio | 43210 | — |
| Local Institution - 0174 | Knoxville | Tennessee | 37920 | — |
| Local Institution - 0228 | Houston | Texas | 77030 | — |
| Local Institution - 0236 | Richmond | Virginia | 23219 | — |
| Local Institution - 0229 | Roanoke | Virginia | 24014 | — |
| Local Institution - 0203 | Kennewick | Washington | 99336 | — |
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 111 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05949684, 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 Jun 29, 2026 · Synced Sep 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05949684 live on ClinicalTrials.gov.