Myelodysplastic Syndrome Clinical Trial
Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
Summary
The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.
Full Description
This study includes an Open-Label Lead in, a Double-Blind component, and an Open-Label High Erythropoietin component. There is a screening period of up to 42 days followed by a treatment period of 52 weeks and a 4-week end of treatment assessment.
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of primary MDS classified by the International Prognostic Scoring System - Revised (IPSS-R) as very low, low or intermediate risk with <5% bone marrow blasts. There is no minimum time from diagnosis to registration/randomization except to allow for proper IPSS-R classification to be made (within 16 weeks prior to randomization), and to show transfusion dependence for participants in both portions of the study.
RBC transfusion of either 2-4 pRBC units during the 8 weeks prior to registration/randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to registration/randomization. Open-Label Lead-in participants only, the requirement to demonstrate transfusion dependence can also be met by a Principal Investigator starting this particular participant on pRBC transfusion during the screening period.
No restriction on prior use of recombinant erythropoietins or analogues (erythropoiesis-stimulating agents [ESAs]), except no ESA use within 8 weeks prior to Day 1 registration/randomization.
Hemoglobin (Hb) ≤10.0 grams/deciliter (g/dL) during screening
Eastern Cooperative Oncology Group (ECOG) of 0-2 at screening
Key Exclusion Criteria:
Diagnosis of secondary MDS associated with prior chemotherapy, extensive radiation therapy (>25% of bone marrow reserve), and or/other significant chemical or radiation exposure
Significant myelofibrosis (>2+ fibrosis)
MDS associated with 5q(del) cytogenetic abnormality
Screen serum erythropoietin level > 400 milli-international units (mIU)/milliliter (mL) • Clinically significant anemia, as determined by the investigator, due to non-MDS etiologies such as iron deficiency, vitamin B12 or folate deficiency, autoimmune or hereditary hemolysis or anemia or hemorrhage or hereditary anemia such as sickle cell anemia or thalassemia.
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There are 67 Locations for this study
Los Angeles California, 91326, United States
Pasadena California, 91105, United States
Torrance California, 90505, United States
Valencia California, 91355, United States
Ventura California, 93003, United States
Westlake Village California, 91361, United States
Whittier California, 90603, United States
Pembroke Pines Florida, 33028, United States
Weston Florida, 33331, United States
Atlanta Georgia, 30322, United States
Saint Louis Missouri, 63110, United States
Canton Ohio, 44718, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Mayfield Heights Ohio, 44124, United States
Philadelphia Pennsylvania, 19106, United States
Houston Texas, 77030, United States
Darlinghurst New South Wales, 2010, Australia
Liverpool New South Wales, 2170, Australia
South Brisbane Queensland, 4101, Australia
Victoria Park Saint Albans, 3021, Australia
Hobart Tasmania, 7000, Australia
Wilrijk Antwerpen, 2610, Belgium
Bruxelles Brussels Capital Region, 1200, Belgium
Hasselt Limburg, 3500, Belgium
Brugge West-Vlaanderen, 8000, Belgium
Freiburg Baden-Wurttemberg, 79106, Germany
Munchen Bayern, 81675, Germany
Münster Nordrhein-Westfalen, 48149, Germany
Dresden Sachsen, 01307, Germany
Leipzig Sachsen, 04103, Germany
Kfar Saba HaMerkaz, 44281, Israel
Zerifin HaMerkaz, 70300, Israel
Nahariya HaZafon, 22100, Israel
Haifa , 34362, Israel
Tel Aviv , 49372, Israel
Tel HaShomer , , Israel
Meldola Ravenna, 47014, Italy
Alessandria , 15121, Italy
Bologna , 40138, Italy
Firenze , 50134, Italy
Genova , 16132, Italy
Ravenna , , Italy
Rimini , , Italy
Terni , 5100, Italy
Torino , , Italy
Varese , 21100, Italy
Incheon Incheon Gwang'yeogsi, 21565, Korea, Republic of
Incheon Incheon Gwangyeogsi, 21565, Korea, Republic of
Hwasun Jeonranamdo, 58128, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Kaluga , 24800, Russian Federation
Moscow , 11112, Russian Federation
Moscow , 12318, Russian Federation
Moscow , 12911, Russian Federation
Omsk , 64401, Russian Federation
Saint Petersburg , 19102, Russian Federation
Saint Petersburg , 19708, Russian Federation
Saint Petersburg , 19734, Russian Federation
Sabadell Barcelona, 08208, Spain
Barcelona Catalunya, 08003, Spain
Pamplona Navarra, 31008, Spain
Barcelona , 08041, Spain
Madrid , 28034, Spain
Madrid , 28050, Spain
Salamanca , 37007, Spain
Sevilla , 41009, Spain
Sevilla , 41013, Spain
Boston Lincolnshire, PE21 , United Kingdom
Harrow , HA1 3, United Kingdom
London , SE5 9, United Kingdom
Manchester , M20 4, United Kingdom
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