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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR TRIFERIC

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Clinical Trials for Triferic

Trial ID Title Status Sponsor Phase Summary
NCT02595437 Triferic Pediatric Pharmacokinetic Protocol Recruiting Rockwell Medical Technologies, Inc. Phase 1/Phase 2 The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, two-period sequential dosing study.
NCT02636049 Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers Completed Rockwell Medical Technologies, Inc. Phase 1 This is a Phase 1, open-label, three-period sequential dosing study being conducted to determine the pharmacokinetics of Triferic iron administered intravenously (IV) to healthy adults.
NCT02739100 Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients Completed Rockwell Medical Technologies, Inc. Phase 1 The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via hemodialysate and via two different intravenous routes in adult patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study.
NCT02767128 Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers Completed Rockwell Medical Technologies, Inc. Phase 1 The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered orally in healthy adult volunteers. It is a randomized multiple treatments, single dose study.
NCT02905981 Triferic IRIDA Protocol Not yet recruiting Rockwell Medical Technologies, Inc. Phase 2 The main purpose is to determine whether Triferic, administered orally with Shohl's solution, is safe and effective for the treatment of iron-refractory iron-deficiency anemia (IRIDA).
NCT02909153 Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis Not yet recruiting Rockwell Medical Technologies, Inc. Phase 1 The main purpose is to determine the pharmacokinetic (PK) profile, maximum concentration (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). It is an open label, dose escalation study.
NCT03303144 Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients Not yet recruiting Rockwell Medical Technologies, Inc. Phase 1/Phase 2 The main purpose is to establish the equivalence of Triferic iron administered via dialysate into the arterial blood line and into the venous blood line
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Triferic

Condition Name

Condition Name for Triferic
Intervention Trials
End Stage Renal Disease 4
Chronic Kidney Disease 1
Anemia 1
Peritoneal Dialysis (PD) 1
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Condition MeSH

Condition MeSH for Triferic
Intervention Trials
Kidney Failure, Chronic 4
Anemia, Iron-Deficiency 2
Renal Insufficiency, Chronic 1
Kidney Diseases 1
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Clinical Trial Locations for Triferic

Trials by Country

Trials by Country for Triferic
Location Trials
United States 10
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Trials by US State

Trials by US State for Triferic
Location Trials
Michigan 2
Florida 2
Texas 1
Ohio 1
Missouri 1
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Clinical Trial Progress for Triferic

Clinical Trial Phase

Clinical Trial Phase for Triferic
Clinical Trial Phase Trials
Phase 2 1
Phase 1/Phase 2 2
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for Triferic
Clinical Trial Phase Trials
Completed 3
Not yet recruiting 3
Recruiting 1
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Clinical Trial Sponsors for Triferic

Sponsor Name

Sponsor Name for Triferic
Sponsor Trials
Rockwell Medical Technologies, Inc. 7
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Sponsor Type

Sponsor Type for Triferic
Sponsor Trials
Industry 7
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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Medtronic
Cipla
AstraZeneca
Chinese Patent Office
Harvard Business School
Cerilliant
Healthtrust
Colorcon

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