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.

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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.

View Eligibility Criteria

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.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

184

Study ID:

NCT03263091

Recruitment Status:

Active, not recruiting

Sponsor:

FibroGen

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There are 67 Locations for this study

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Investigational Site
Los Angeles California, 91326, United States
Investigational Site
Pasadena California, 91105, United States
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Torrance California, 90505, United States
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Valencia California, 91355, United States
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Ventura California, 93003, United States
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Westlake Village California, 91361, United States
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Whittier California, 90603, United States
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Pembroke Pines Florida, 33028, United States
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Weston Florida, 33331, United States
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Atlanta Georgia, 30322, United States
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Saint Louis Missouri, 63110, United States
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Canton Ohio, 44718, United States
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Cleveland Ohio, 44111, United States
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Cleveland Ohio, 44195, United States
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Mayfield Heights Ohio, 44124, United States
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Philadelphia Pennsylvania, 19106, United States
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Houston Texas, 77030, United States
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Darlinghurst New South Wales, 2010, Australia
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Liverpool New South Wales, 2170, Australia
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South Brisbane Queensland, 4101, Australia
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Victoria Park Saint Albans, 3021, Australia
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Hobart Tasmania, 7000, Australia
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Wilrijk Antwerpen, 2610, Belgium
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Bruxelles Brussels Capital Region, 1200, Belgium
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Hasselt Limburg, 3500, Belgium
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Brugge West-Vlaanderen, 8000, Belgium
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Freiburg Baden-Wurttemberg, 79106, Germany
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Munchen Bayern, 81675, Germany
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Münster Nordrhein-Westfalen, 48149, Germany
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Dresden Sachsen, 01307, Germany
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Leipzig Sachsen, 04103, Germany
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Kfar Saba HaMerkaz, 44281, Israel
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Zerifin HaMerkaz, 70300, Israel
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Nahariya HaZafon, 22100, Israel
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Haifa , 34362, Israel
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Tel Aviv , 49372, Israel
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Tel HaShomer , , Israel
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Meldola Ravenna, 47014, Italy
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Alessandria , 15121, Italy
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Bologna , 40138, Italy
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Firenze , 50134, Italy
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Genova , 16132, Italy
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Ravenna , , Italy
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Rimini , , Italy
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Terni , 5100, Italy
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Torino , , Italy
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Varese , 21100, Italy
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Incheon Incheon Gwang'yeogsi, 21565, Korea, Republic of
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Incheon Incheon Gwangyeogsi, 21565, Korea, Republic of
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Hwasun Jeonranamdo, 58128, Korea, Republic of
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Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
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Kaluga , 24800, Russian Federation
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Moscow , 11112, Russian Federation
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Moscow , 12318, Russian Federation
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Moscow , 12911, Russian Federation
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Omsk , 64401, Russian Federation
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Saint Petersburg , 19102, Russian Federation
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Saint Petersburg , 19708, Russian Federation
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Saint Petersburg , 19734, Russian Federation
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Sabadell Barcelona, 08208, Spain
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Barcelona Catalunya, 08003, Spain
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Pamplona Navarra, 31008, Spain
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Barcelona , 08041, Spain
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Madrid , 28034, Spain
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Madrid , 28050, Spain
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Salamanca , 37007, Spain
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Sevilla , 41009, Spain
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Sevilla , 41013, Spain
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Boston Lincolnshire, PE21 , United Kingdom
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Harrow , HA1 3, United Kingdom
Investigational Site
London , SE5 9, United Kingdom
Investigational Site
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

184

Study ID:

NCT03263091

Recruitment Status:

Active, not recruiting

Sponsor:


FibroGen

How clear is this clinincal trial information?

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