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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR AURYXIA

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Clinical Trials for Auryxia

Trial ID Title Status Sponsor Phase Summary
NCT01554982 A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis Completed Keryx Biopharmaceuticals Phase 3 A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.
NCT02492620 Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D Recruiting Keryx Biopharmaceuticals Phase 3 It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The investigators further hypothesize that effective treatment of anemia and mineral metabolism with FC in the pre-dialysis and transition period will result in improved physical functioning, reduced hospitalization and reduced total cost of care when compared to participants receiving contemporaneously provided standard of care therapy.
NCT02492620 Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D Recruiting Denver Nephrologists, P.C. Phase 3 It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The investigators further hypothesize that effective treatment of anemia and mineral metabolism with FC in the pre-dialysis and transition period will result in improved physical functioning, reduced hospitalization and reduced total cost of care when compared to participants receiving contemporaneously provided standard of care therapy.
NCT02661295 A Study of Ferric Citrate to Improve Inflammation and Lipid Levels Recruiting Keryx Biopharmaceuticals Phase 4 The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.
NCT02661295 A Study of Ferric Citrate to Improve Inflammation and Lipid Levels Recruiting Winthrop University Hospital Phase 4 The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.
NCT02888171 Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency Recruiting University of Alabama at Birmingham N/A The main objective of the study is to compare the impact of oral ferric citrate compared to standard of care oral ferrous sulfate on serum iron, percent transferrin saturation, ferritin, hepcidin and hemoglobin levels in individuals with moderate to severe chronic kidney disease (CKD) and absolute iron deficiency.
NCT03055598 Ferric Citrate in ESRD Pilot Project Recruiting Keryx Biopharmaceuticals Phase 4 This research study is for participants that have End Stage Renal Disease (ESRD). ESRD is the last stage of chronic kidney disease. Anemia is very common in ESRD patients and require erythropoiesis-stimulating agents (ESAs) for treatment. Anemia happens when there are not enough red blood cells in your body. ESAs work by helping the bone marrow to produce red blood cells. There are two ESAs licensed for the treatment of anemia of CKD in the Unites States: epoetin alfa and darbopoetin alfa. ESA therapy is considered safe. However, major adverse effects should be acknowledged, including an increased risk of death, thromboembolic complications, stroke, heart attack, aplastic anemia, tumor progression, and others. To minimize risks of these adverse events, careful monitoring of hemoglobin levels, along with adjustment of ESA dosing, to maintain the lowest hemoglobin level clinically needed is recommended. Ferric Citrate, also called Auryxia, is an iron-based phosphate binder that may decrease ESA usage while maintaining hemoglobin levels. Phosphate binders are medications used to reduce the body's absorption of phosphate. In a prior study, it was seen that some laboratory values, such as iron levels, changed positively in response to Auryxia. In this study we want to see if using Auryxia will cause a change in laboratory values and lower the use of ESAs in ESRD patients.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Auryxia

Condition Name

Condition Name for Auryxia
Intervention Trials
Hyperphosphatemia 4
End Stage Renal Disease 3
Chronic Kidney Disease 2
Chronic Kidney Diseases 1
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Condition MeSH

Condition MeSH for Auryxia
Intervention Trials
Renal Insufficiency, Chronic 4
Kidney Diseases 4
Hyperphosphatemia 4
Kidney Failure, Chronic 3
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Clinical Trial Locations for Auryxia

Trials by Country

Trials by Country for Auryxia
Location Trials
United States 22
Puerto Rico 1
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Trials by US State

Trials by US State for Auryxia
Location Trials
Texas 2
California 2
Colorado 2
North Carolina 1
Illinois 1
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Clinical Trial Progress for Auryxia

Clinical Trial Phase

Clinical Trial Phase for Auryxia
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
N/A 1
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Clinical Trial Status

Clinical Trial Status for Auryxia
Clinical Trial Phase Trials
Recruiting 4
Active, not recruiting 1
Completed 1
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Clinical Trial Sponsors for Auryxia

Sponsor Name

Sponsor Name for Auryxia
Sponsor Trials
Keryx Biopharmaceuticals 5
Kaiser Permanente 1
Sreedhar Mandayam 1
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Sponsor Type

Sponsor Type for Auryxia
Sponsor Trials
Other 5
Industry 5
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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Cipla
Teva
McKinsey
McKesson
Moodys
Cantor Fitzgerald
UBS
QuintilesIMS

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