Status:
TERMINATED
Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
Lead Sponsor:
FibroGen
Collaborating Sponsors:
AstraZeneca
Astellas Pharma Inc
Conditions:
Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts)
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT03263091
Start Date
January 29 2018
End Date
June 20 2023
Last Update
August 1 2024
Active Locations (124)
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1
Investigational Site
Bakersfield, California, United States, 93309
2
Investigational Site
Beverly Hills, California, United States, 90212
3
Investigational Site
Burbank, California, United States, 90212
4
Investigational Site
Encino, California, United States, 91436