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Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants — IMPACT  

Renal Insufficiency Clinical Trial

Official title:
A Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Impact of Auryxia (Ferric Citrate) on Erythropoiesis-Stimulating Agent (ESA) Use, Intravenous (IV) Iron Use, Phosphate Control, and Anemia Control in Adult Participants on In-Center Hemodialysis or Home Dialysis

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04922645
Study type Interventional
Source USRC Kidney Research
Contact
Status Completed
Phase Phase 4
Start date June 29, 2021
Completion date September 15, 2022
View Details
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