CLINICAL TRIALS PROFILE FOR FERRIC PYROPHOSPHATE CITRATE
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All Clinical Trials for FERRIC PYROPHOSPHATE CITRATE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02595437 ↗ | Triferic Pediatric Pharmacokinetic Protocol | Completed | Rockwell Medical Technologies, Inc. | Phase 1/Phase 2 | 2015-11-01 | 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 | 2015-10-01 | 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 | 2016-04-01 | 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 | 2016-04-01 | 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 (Iron-Refractory Iron-Deficiency Anemia) Protocol | Terminated | Rockwell Medical Technologies, Inc. | Phase 2 | 2017-01-17 | 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 | Completed | Rockwell Medical Technologies, Inc. | Phase 1 | 2017-01-01 | 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 | Completed | Rockwell Medical Technologies, Inc. | Phase 1/Phase 2 | 2017-10-01 | 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 | >Start Date | >Summary |
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