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Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden

NCT03263091

TerminatedPhase 3

Sponsor: Kyntra Bio

Conditions: Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Anemia

Interventions: Roxadustat, Placebo

Countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, India

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (124)

Bakersfield, California, United States
Beverly Hills, California, United States
Burbank, California, United States
Encino, California, United States
Laguna Hills, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Oceanside, California, United States
Pasadena, California, United States
Santa Maria, California, United States
Torrance, California, United States
Valencia, California, United States
Ventura, California, United States
Westlake Village, California, United States
Whittier, California, United States
Grand Junction, Colorado, United States
Pembroke Pines, Florida, United States
Weston, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
St Louis, Missouri, United States
Charlotte, North Carolina, United States
Canton, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Mayfield Heights, Ohio, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Houston, Texas, United States
Charlottesville, Virginia, United States
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