Ferric pyrophosphate citrate

Generic Name: Ferric pyrophosphate citrate

Brand Names: Triferic

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₄Fe_₄O_₄₂P_₆

CAS Number: 1802359-96-1

Unique Ingredient Identifier: UBY79OCO9G

Background: Ferric pyrophosphate citrate is a soluble iron replacement product. Free iron presents several side effects as it can catalyze free radical formation and lipid peroxidation as well as the presence of interactions of iron in plasma. The ferric ion is strongly complexed by pyrophosphate and citrate. FPC is categorized in Japan as a second class OTC drug. This ...

Indication: Ferric pyrophosphate citrate is indicated for the treatment of iron loss or iron deficiency to maintain hemoglobin and to reduce the prescribed dose of erythropoiesis-stimulating agent (ESA) required to maintain desired hemoglobin levels.
...

Associated Conditions: Iron Deficiency (ID)

Associated Therapies: -

Clinical Trials

Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.

Phase 1

Completed

Conditions: End Stage Renal Disease

Interventions: Drug: Triferic

First Posted Date: 2020-06-01

Last Posted Date: 2021-07-13

Lead Sponsor: Rockwell Medical Technologies, Inc.

Target Recruit Count: 23

Registration Number: NCT04409132

Locations: 🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States

Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC)

Phase 3

Conditions: End Stage Renal Disease

Interventions: Drug: Triferic

First Posted Date: 2020-01-27

Last Posted Date: 2021-04-21

Lead Sponsor: Rockwell Medical Technologies, Inc.

Target Recruit Count: 150

Registration Number: NCT04239391

Locations: 🇺🇸
Children's Mercy Hospital, Kansas City, Missouri, United States
🇺🇸
Loma Linda University Hospital, Loma Linda, California, United States
🇺🇸
Riley Hospital for Children at Indiana University, Indianapolis, Indiana, United States

and more 6 locations

A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

Phase 1

Completed

Conditions: End Stage Renal Disease

Interventions: Drug: Triferic
Drug: Heparin

First Posted Date: 2019-08-01

Last Posted Date: 2020-12-02

Lead Sponsor: Rockwell Medical Technologies, Inc.

Target Recruit Count: 12

Registration Number: NCT04042324

Locations: 🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States

Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients

Phase 1

Completed

Conditions: End Stage Renal Disease

Interventions: Drug: Triferic

First Posted Date: 2017-10-05

Last Posted Date: 2020-11-16

Lead Sponsor: Rockwell Medical Technologies, Inc.

Target Recruit Count: 27

Registration Number: NCT03303144

Locations: 🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States

Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis

Phase 1

Completed

Conditions: Anemia
Peritoneal Dialysis (PD)
Chronic Kidney Disease

Interventions: Drug: Triferic

First Posted Date: 2016-09-21

Last Posted Date: 2019-08-08

Lead Sponsor: Rockwell Medical Technologies, Inc.

Target Recruit Count: 30

Registration Number: NCT02909153

Triferic IRIDA (Iron-Refractory Iron-Deficiency Anemia) Protocol

Phase 2

Terminated

Conditions: Iron-Refractory Iron-Deficiency Anemia

Interventions: Drug: Fer-In-Sol
Drug: Shohl's solution
Drug: Triferic

First Posted Date: 2016-09-19

Last Posted Date: 2020-09-22

Lead Sponsor: Rockwell Medical Technologies, Inc.

Target Recruit Count: 1

Registration Number: NCT02905981

Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers

Phase 1

Completed

Conditions: Iron-refractory, Iron-deficiency Anemia (IRIDA)

Interventions: Drug: Fer-In-Sol
Drug: Triferic
Drug: Shohl's solution

First Posted Date: 2016-05-10

Last Posted Date: 2019-02-01

Lead Sponsor: Rockwell Medical Technologies, Inc.

Target Recruit Count: 14

Registration Number: NCT02767128

Locations: 🇺🇸
Jasper Clinic, Kalamazoo, Michigan, United States

Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients

Phase 1

Completed

Conditions: End Stage Renal Disease

Interventions: Drug: Triferic

First Posted Date: 2016-04-14

Last Posted Date: 2019-02-01

Lead Sponsor: Rockwell Medical Technologies, Inc.

Target Recruit Count: 13

Registration Number: NCT02739100

Locations: 🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States

Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers

Phase 1

Completed

Conditions: End Stage Renal Disease

Interventions: Drug: Triferic

First Posted Date: 2015-12-21

Last Posted Date: 2019-08-20

Lead Sponsor: Rockwell Medical Technologies, Inc.

Target Recruit Count: 12

Registration Number: NCT02636049

Locations: 🇺🇸
Jasper Clinic, Kalamazoo, Michigan, United States

Triferic Pediatric Pharmacokinetic Protocol

Phase 1

Completed

Conditions: End Stage Renal Disease

Interventions: Drug: Triferic

First Posted Date: 2015-11-03

Last Posted Date: 2018-10-25

Lead Sponsor: Rockwell Medical Technologies, Inc.

Target Recruit Count: 22

Registration Number: NCT02595437

Locations: 🇺🇸
Lucile Packard Childrens Hospital, Stanford, California, United States
🇺🇸
Nemours/A. I. DuPont Hospital for Children, Wilmington, Delaware, United States
🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States

and more 6 locations

Drug Development Updates

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