Elritercept vs Epoetin Alfa for Anemia
(ELRiSE MDS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The main aim of this study is to assess how elritercept works in lowering the need for RBC (red blood cell) transfusions and how safe elritercept is when compared with epoetin alfa. Other aims are to learn if elritercept improves tiredness as reported by participants without needing RBC transfusion compared with epoetin alfa, the RBC transfusion burden and quality of life compared with epoetin alfa. The study also aims to find out the extent of the immune response to elritercept. The study will also check on the medical problems (safety) of elritercept.
Who Is on the Research Team?
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either elritercept or epoetin alfa to assess efficacy and safety in reducing RBC transfusion needs
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to be monitored for long-term outcomes and safety
What Are the Treatments Tested in This Trial?
Interventions
- Elritercept
- Epoetin Alfa
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive a starting dose of elritercept at 3.75 milligrams per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks, and may have the dose escalated to 5.0 mg/kg if needed,
Participants will receive a starting dose of epoetin Alfa at 450 international units per kilograms (IU/kg) administered SC once every week, and may have the dose escalated up to 1050 IU/kg.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier
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