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Brief Title: A Study of KER-050 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
Official Title: 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)
Study ID: NCT04419649
Brief Summary: The purpose of this study is to evaluate the effects of KER-050 on anemia in patients with very low, low or intermediate risk MDS.
Detailed Description: KER-050 is a therapeutic protein designed to increase red blood cell and platelet production by inhibiting the signaling of a subset of the transforming growth factor beta (TGF-ß) family of proteins to promote hematopoiesis. It is being developed for the treatment of low blood cell counts, or cytopenias including anemia and thrombocytopenia in patients with Myelodysplastic Syndrome (MDS) and Myelofibrosis (MF).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
University of Miami, Sylvester Comprehensive Cancer Center, 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 Unit, Albury, New South Wales, Australia
The 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
Box Hill 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 and Haematology Service, Wendouree, Victoria, Australia
Fakultni Nemocnice Brno, Brno, , Czechia
Fakultni Nemocnice Kralovske Vinohrady, Praha, , Czechia
Vseobecna Fakultni Nemocnice Praha, Praha, , Czechia
CHU Angers - Hôpital Hôtel Dieu, Angers, , France
CHU de Nantes - Hotel Dieu, Nantes, , France
CHU Nice - Hôpital de l'Archet, Nice, , France
Hôpital Saint-Louis, Paris, , France
CH René-Dubos, Pontoise, , France
CHU de Bordeaux - Hôpital Haut-Lévêque, Talence, , France
Centre Hospitalier de la Région d'Annecy, Épagny, , France
Klinikum Bayreuth GmbH, Bayreuth, , Germany
Marien Hospital Dusseldorf GMBH, Düsseldorf, , Germany
Universitaetsklinikum Duesseldorf AoeR, Düsseldorf, , Germany
Klinikum Esslingen GmbH, Esslingen, , Germany
Universitaetsklinikum Leipzig AoeR, Leipzig, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz, , Germany
Universitaetsmedizin Rostock, Rostock, , Germany
Sheba Medical Center, Ramat Gan, , Israel
Tel-Aviv Sourasky 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, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain