COMPANY

Rockwell Medical

HQ: Wixom, MI source · rockwellmed.com ↗

FDA-cleared device company Clinical Phase 3

Keywords: renal end stage renal disease Chronic Kidney Disease Renal Failure Chronic Requiring Hemodialysis Iron Deficiency Anemia End-Stage Renal Disease Iron-Refractory Iron-Deficiency Anemia Peritoneal Dialysis Anemia Iron-refractory, Iron-deficiency Anemia Kidney Failure Triferic Triferic AVNU Soluble Ferric Pyrophosphate

Location: Wixom, MI · source · Aug 13, 2026

Profile checked Oct 10, 2026

19Trials (company is sponsor)

Timeline

Nov 30, 2021 Trial start Phase 2: Treatment of (IDA) by (FPC) Delivered Via Infusion Pump in Patients Receiving Home Infusion Therapy source ↗
Apr 19, 2021 Trial start Phase 4: Triferic AVNU Infusion Via Freedom Pump During Hemodialysis source ↗
Sep 1, 2020 Trial start Phase 3: Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC) source ↗
Jun 25, 2020 Trial start Phase 1/Phase 2: Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus. source ↗
Sep 30, 2019 Trial start Phase 1/Phase 2: A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients source ↗
Oct 1, 2017 Trial start Phase 1/Phase 2: Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients source ↗
Jan 17, 2017 Trial start Phase 2: Triferic IRIDA (Iron-Refractory Iron-Deficiency Anemia) Protocol source ↗
2017-01 Trial start Phase 1: Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis source ↗
2016-04 Trial start Phase 1: Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients source ↗
2016-04 Trial start Phase 1: Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers source ↗
Nov 1, 2015 Trial start Phase 1/Phase 2: Triferic Pediatric Pharmacokinetic Protocol source ↗
2015-10 Trial start Phase 1: Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers source ↗
2013-07 Trial start Phase 1/Phase 2: Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients source ↗
2013-06 Trial start Phase 1: A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers. source ↗
2011-11 Trial start Phase 3: Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis source ↗
2011-04 Trial start Phase 3: Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2) source ↗
2011-03 Trial start Phase 3: Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients source ↗
2011-01 Trial start Phase 2: Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients source ↗
2007-08 Trial start Phase 2: Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis source ↗

Clinical trials (lead sponsor) 19

Record	Title	Phase	Status	Start	Primary completion
NCT04689932	Triferic AVNU Infusion Via Freedom Pump During Hemodialysis	Phase 4	Completed	Apr 19, 2021	Jun 19, 2021 (actual)
NCT05110768	Treatment of (IDA) by (FPC) Delivered Via Infusion Pump in Patients Receiving Home Infusion Therapy	Phase 2	Unknown status (ClinicalTrials.gov)	Nov 30, 2021	Apr 30, 2022 (estimated)
NCT04409132	Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.	Phase 1/Phase 2	Completed	Jun 25, 2020	Apr 2, 2021 (actual)
NCT04239391	Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC)	Phase 3	Unknown status (ClinicalTrials.gov)	Sep 1, 2020	Aug 31, 2023 (estimated)
NCT04042324	A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients	Phase 1/Phase 2	Completed	Sep 30, 2019	Jan 16, 2020 (actual)
NCT00548249	Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis	Phase 2	Completed	2007-08	2009-10 (actual)
NCT03303144	Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients	Phase 1/Phase 2	Completed	Oct 1, 2017	Dec 28, 2017 (actual)
NCT02905981	Triferic IRIDA (Iron-Refractory Iron-Deficiency Anemia) Protocol	Phase 2	Terminated	Jan 17, 2017	Mar 15, 2018 (actual)
NCT02636049	Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers	Phase 1	Completed	2015-10	2015-10 (actual)
NCT02909153	Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis	Phase 1	Completed	2017-01	2017-07 (actual)
NCT02739100	Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients	Phase 1	Completed	2016-04	2016-07 (actual)
NCT02767128	Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers	Phase 1	Completed	2016-04	2016-04 (actual)
NCT02595437	Triferic Pediatric Pharmacokinetic Protocol	Phase 1/Phase 2	Completed	Nov 1, 2015	2016-12 (actual)
NCT01286012	Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients	Phase 2	Completed	2011-01	2013-01 (actual)
NCT01320202	Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients	Phase 3	Completed	2011-03	2013-05 (actual)
NCT01322347	Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)	Phase 3	Completed	2011-04	2014-01 (actual)
NCT01503021	Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis	Phase 3	Completed	2011-11	2014-01 (actual)
NCT01894906	Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients	Phase 1/Phase 2	Completed	2013-07	2013-09 (actual)
NCT01920854	A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.	Phase 1	Completed	2013-06	2013-09 (actual)