This study is being conducted to demonstrate the effect of Auryxia, when used as the primary phosphate lowering therapy, on the overall cumulative use of erythropoiesis-stimulating agent and intravenous iron as well as on the laboratory parameters indicative of phosphate and anemia management.
Approximately 200 participants will be randomized 1:1 (stratified by modality and hemoglobin level) to receive either Auryxia or standard of care phosphate lowering therapy to determine the impact of Auryxia when used as the primary phosphate lowering therapy as compared to standard of care on the utilization of erythropoiesis-stimulating agent and intravenous iron in both in-center and home dialysis populations. This study will also seek to determine the impact of Auryxia, when used as the primary phosphate lowering therapy versus standard of care, on the biochemical assessments of serum phosphate and hemoglobin in both in-center and home dialysis populations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
214
Ferric citrate is an iron-based phosphate binder for the treatment of hyperphosphatemia in subjects with dialysis-dependent chronic kidney disease (DD CKD) and for the treatment of iron deficiency anemia (IDA) in subjects with non-dialysis dependent chronic kidney disease (NDD CKD).
Subjects randomized to SOC will continue their currently prescribed dose of phosphate lowering therapy which will be dosed per local standard of care to achieve community target serum phosphate goals.
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Difference in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups
Difference in change from baseline period (Month -3 to Day 1) to months 4 to 6 (efficacy evaluation period) in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups.
Time frame: Baseline period (Month -3 to Day 1) to months 4to 6 (efficacy evaluation period)
Difference in mean dose of intravenous iron (milligram per month) between Auryxia and standard of care treatment groups.
Difference in change from baseline period to efficacy evaluation period in mean dose of intravenous iron (milligrams per month) between Auryxia and standard of care treatment groups.
Time frame: Baseline period (Month -3 to Day 1) to months 4 to6 (efficacy evaluation period)
Difference in hemoglobin measurements
Difference in proportion of measurements with hemoglobin at or above 10.0 grams per deciliter between Auryxia and standard of care treatment groups during efficacy evaluation period.
Time frame: Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period).
Difference in serum phosphate measurements
Difference in proportion of measurements with serum phosphate at or below 5.5 milligrams per deciliter between Auryxia and standard of care treatment groups during efficacy evaluation period.
Time frame: Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period)
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