Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT03682536 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG Luspatercept
- DRUG Epoetin alfa
Study Locations (20)
Florida
- Local Institution - 119 — Hudson
- Local Institution - 120 — St. Petersburg
- Local Institution - 122 — Tallahassee
- Local Institution - 108 — Tampa
- Local Institution - 118 — West Palm Beach
California
- Local Institution - 107 — Berkeley
- Local Institution - 115 — San Diego
- Local Institution - 101 — Whittier
New Jersey
- Local Institution - 134 — East Brunswick
- Local Institution - 113 — Hackensack
Connecticut
- Local Institution - 104 — New Haven
District of Columbia
- Local Institution - 136 — Washington D.C.
Kentucky
- Local Institution - 102 — Paducah
Maryland
- Local Institution - 123 — Bethesda
Missouri
- Local Institution - 117 — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2019-01-02 |
| Est. Completion | 2027-09-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03682536
The ClinicalTrials.gov registry entry for NCT03682536 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 363 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions — of which Luspatercept is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03682536 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, California, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03682536 about?
NCT03682536 is a clinical study titled "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". 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 ...
What is the current status of trial NCT03682536?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 363 participants. The study started on 2019-01-02. Estimated completion is 2027-09-28.
What conditions does trial NCT03682536 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03682536?
The interventions under investigation include: Luspatercept (DRUG), Epoetin alfa (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03682536?
This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03682536 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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