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Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03682536

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.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 12:32 PM EDT

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

Study identification

NCT ID
NCT03682536
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Celgene
Industry
Enrollment
363 participants

Conditions and interventions

Interventions

  • Luspatercept Drug
  • Epoetin alfa Drug

Drug

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 1, 2019
Primary completion
Mar 30, 2023
Completion
Sep 27, 2027
Last update posted
Nov 19, 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 19, 2024 · Synced Jul 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03682536 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →