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Last Updated: August 14, 2020

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CLINICAL TRIALS PROFILE FOR FERRIC CITRATE

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505(b)(2) Clinical Trials for Ferric Citrate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00967993 Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease Completed Keryx Biopharmaceuticals Phase 2 2010-01-01 The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage renal disease (ESRD).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ferric Citrate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00648167 A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) Completed Collaborative Study Group (CSG) Phase 2 2008-03-01 This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.
NCT00648167 A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) Completed Keryx Biopharmaceuticals Phase 2 2008-03-01 This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.
NCT00967993 Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease Completed Keryx Biopharmaceuticals Phase 2 2010-01-01 The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage renal disease (ESRD).
NCT01074125 A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease Completed Collaborative Study Group (CSG) Phase 3 2010-05-01 This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.
NCT01074125 A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease Completed Keryx Biopharmaceuticals Phase 3 2010-05-01 This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.
NCT01191255 A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis Completed Keryx Biopharmaceuticals Phase 3 2010-10-01 This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
NCT01503736 A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease Completed Panion & BF Biotech Inc. Phase 3 2010-06-01 The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ferric Citrate

Condition Name

Condition Name for Ferric Citrate
Intervention Trials
Hyperphosphatemia 12
End Stage Renal Disease 11
End-stage Renal Disease 4
ESRD 4
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Condition MeSH

Condition MeSH for Ferric Citrate
Intervention Trials
Kidney Diseases 17
Kidney Failure, Chronic 16
Renal Insufficiency, Chronic 16
Hyperphosphatemia 12
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Clinical Trial Locations for Ferric Citrate

Trials by Country

Trials by Country for Ferric Citrate
Location Trials
United States 98
Puerto Rico 4
Israel 3
Taiwan 2
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Trials by US State

Trials by US State for Ferric Citrate
Location Trials
Texas 8
California 6
Florida 6
Colorado 6
Michigan 6
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Clinical Trial Progress for Ferric Citrate

Clinical Trial Phase

Clinical Trial Phase for Ferric Citrate
Clinical Trial Phase Trials
Phase 4 5
Phase 3 9
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Ferric Citrate
Clinical Trial Phase Trials
Completed 12
Recruiting 8
Not yet recruiting 5
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Clinical Trial Sponsors for Ferric Citrate

Sponsor Name

Sponsor Name for Ferric Citrate
Sponsor Trials
Keryx Biopharmaceuticals 13
Rockwell Medical Technologies, Inc. 8
Panion & BF Biotech Inc. 3
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Sponsor Type

Sponsor Type for Ferric Citrate
Sponsor Trials
Industry 25
Other 8
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