The study is designed to determine the efficacy and safety of roxadustat for the treatment of anemia due to very low, low, or intermediate risk MDS in participants with high transfusion burden (HTB).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
201
Roxadustat will be administered per schedule specified in the arm description.
Placebo matching to roxadustat will be administered per schedule specified in the arm description.
Percentage of Participants With Red Blood Cell-transfusion Independence (RBC-TI) Over Any Consecutive 56-day Period
Time frame: Week 1 through Week 24
Percentage of Participants With RBC-TI Over Any Consecutive 84-day Period
Time frame: Week 1 through Week 48 or end of treatment (EOT; up to 5 years)
Percentage of Participants With RBC-TI Over Any Consecutive 112-day Period
Time frame: Week 1 through Week 48 or EOT (up to 5 years)
Percentage of Participants With ≥50% Reduction in Rate of Total Red Blood Cell (RBC) Units Transfused During a 16-week Period
Time frame: Week 1 through Week 48 or EOT (up to 5 years)
Percentage of Participants With RBC-TI Over Any Consecutive 168-day Period
Time frame: Week 1 through Week 48 or EOT (up to 5 years)
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