RecruitingPhase 2NCT04419649

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

Sponsor

Takeda

Enrollment

160 participants

Start Date

Aug 19, 2020

Study Type

INTERVENTIONAL

Conditions

Myelodysplastic Syndromes Cytopenia

Summary

The main aim of this study is to learn how safe elritercept is and how well adults with anemia associated with lower-risk MDS tolerate treatment with different doses of elritercept. Other aims are to learn how safe elritercept is by looking at how many participants have MDS that worsens during the study and learn about the effects of elritercept on anemia linked to MDS. The study will also look to learn how elritercept affects the production of healthy RBCs.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Elritercept for people with cytopenia and myelodysplastic syndromes. The study is currently recruiting participants at 47 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElritercept

Elritercept SC injection.

Locations(47)

City of Hope National Medical Center

Duarte, California, United States

University of Miami School of Medicine Sylvester Comprehensive Cancer Center (SCCC)

Miami, Florida, United States

H. Lee Moffitt Cancer Center and Research Center

Tampa, Florida, United States

Karmanos Cancer Institute at Mclaren Greater Lansing

Lansing, Michigan, United States

University of Pittsburgh Medical Health Center

Pittsburgh, Pennsylvania, United States

Border Medical Oncology Research

Albury, New South Wales, Australia

Tweed Hospital

Tweed Heads, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Townsville University Hospital

Douglas, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Boxhill Hospital

Box Hill, Victoria, Australia

University Hospital Geelong

Geelong, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

St Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

Ballarat Oncology & Haematology Service

Wendouree, Victoria, Australia

Fakultni nemocnice Brno

Brno, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Vseobecna Fakultni Nemocnice Praha

Prague, Czechia

CHU Angers - Hopital Hotel Dieu

Angers, France

Centre Hospitalier de la Region dAnnecy

Épagny, France

CHU de Nantes - Hotel Dieu

Nantes, France

CHU Nice - Hopital de l'Archet 1

Nice, France

Hopital Saint-Louis

Paris, France

CH Rene-Dubos

Pontoise, France

CHU de Bordeaux - Hopital Haut-Leveque

Talence, France

Klinikum Bayreuth GmbH

Bayreuth, Germany

Charite-Campus Benjamin Franklin

Berlin, Germany

Praxis am Volkspark Berlin

Berlin, Germany

University Hospital Bonn

Bonn, Germany

Marien Hospital Dusseldorf GMBH

Düsseldorf, Germany

Universitaetsklinikum Duesseldorf AoeR

Düsseldorf, Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, Germany

University Hospital Halle (Saale)

Halle, Germany

Universitaetsklinikum Leipzig AoeR

Leipzig, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, Germany

Universitaetsmedizin Rostock

Rostock, Germany

Sheba Medical Center - Sheba Fund for Health Services and Research

Ramat Gan, Israel

Sourasky Medical Center - Infrastructure and Health Services Fund of the Tel Aviv Medical Center

Tel Aviv, Israel

Middlemore Hospital

Auckland, New Zealand

Hospital Universitario Central de Asturias

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

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NCT04419649

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