Clareo Health | Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
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Keep this study
Lead
Kyntra Bio
With
AstraZeneca
Astellas Pharma Inc
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
