To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
167
Unnamed facility
Peoria, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Change in Hb Concentration From Baseline to Week 16
Change in hemoglobin concentration from baseline to Week 16.
Time frame: 16 weeks
Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16
Number of subjects that achieve an increase in Hemoglobin concentration of ≥1 g/dL at Week 16
Time frame: 16 weeks
Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16
Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16
Time frame: 16 weeks
Change in Hb Concentration From Baseline to Week 8
Change in Hemoglobin concentration from baseline to Week 8
Time frame: 8 weeks
Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16
Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16
Time frame: 16 weeks
Changes in Ferritin From Baseline to Week 16
Changes in iron parameter - ferritin - from baseline to week 16
Time frame: baseline to week 16
Number of Participants With (TEAEs)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Week 16
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
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Unnamed facility
Prescott, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
La Mesa, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Roseville, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Coral Springs, Florida, United States
...and 17 more locations
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase
Time frame: Week 16
Changes in TSAT From Baseline to Week 16
Changes in iron parameters - TSAT - from baseline to week 16
Time frame: baseline to week 16
Changes in Iron Parameter From Baseline to Week 16
Changes in iron parameters - serum iron - from baseline to week 16
Time frame: from baseline to week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase
Time frame: Week 52
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase
Time frame: Week 52