Efficacy and Safety of FG-4592 for Treatment of Anemia in Patients With Lower Risk MDS With Low Red Blood Cell Transfusion Burden
Trial ID or NCT#
NCT03263091
Status
NOT RECRUITING
Purpose
The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in patients with Lower Risk Myelodysplastic Syndrome and Low Red Blood Cell Transfusion Burden.
Official Title
A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Diagnosis of primary MDS classified as very low, low or intermediate risk with <5% blasts. There is no minimum time from diagnosis except to allow for proper IPSS-R classification to be made, and to show transfusion dependence. - RBC transfusion of either 2-4 pRBC units over the 8 weeks prior to randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to randomization - No restriction on prior use of ESAs, except no ESA use within 8 weeks prior to registration/randomization - Pre-transfusion hemoglobin of <= 10 g/dL, - ECOG of 0-2 at screen - History of cured malignancy with no evidence of recurrence for a least 3 years are eligible Key
Exclusion Criteria:
- - Diagnosis of secondary MDS - Significant myelofibrosis (>2+fibrosis) - MDS associated with 5q(del) abnormality - Screen serum erythropoietin level > 400 mIU/mL (Double Blind); for Open- Label High Erythropoietin patients serum erythropoietin level must be >400 mIU/mL - Clinically significant anemia due to non-MDS etiologies
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Robert Jones
650-497-6694
View on ClinicalTrials.gov
