Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Triferic · 8 trials · 5 indications
The PK will be done by assessing the mean Cmax of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.6 mg iron/kg during a single dialysis session.
The PK will be done by assessing the mean AUC(0-end) of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.5 mg iron/kg during a single dialysis session.
The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
The PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
The PK will be done by assessing the AUC from time zero to 12 hours after infusion (AUC0-12) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
The PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
The PK will be done by assessing the AUC from time zero to 12 hours after the infusion (AUC0-12) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
The PK will be done by assessing the mean area under the serum concentration-time curve from time zero to the time of the last quantified concentration (AUC(last)) and comparing between Triferic administered via hemodialysate and Triferic administered at a fixed IV dose of 6.6 mg iron/kg (pre-dialyzer and post-dialyzer) during a single dialysis session.
The outcome will be measured by assessing the Cmax of total iron with multiple different oral iron treatment. The following oral iron dosing treatments will be measured: Treatment A (Fer-in-Sol 3 mg iron/kg), Treatment B (Shohl's solution followed after 10 minutes by Fer-In-Sol, 3 mg/kg), Treatment C (Triferic 3 mg iron/kg), Treatment D (Shohl's solution followed after 10 minutes by Triferic 3 mg/kg), Treatment E (Shohl's solution followed immediately by Triferic 3 mg/kg), Treatment F (Triferic 6.6 mg IV over 4 hours)
The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC(last) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC(last) factors out the iron present in the serum prior to dosing and includes the administered iron only.
The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC (0-end) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC (0-end) factors out the iron present in the serum prior to dosing and includes the administered iron only.
Blood samples will be drawn at time = 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 16 hours after the start of Triferic administration on study Day 2 (IV infusion of 6 mg Triferic over 3 hours) and Day 3 (35 microgram/kg IV dose of Triferic given over 30 - 60 seconds) in order to determine the Peak Serum Concentration, corrected (Cmax) of total serum iron.
Blood samples will be drawn at time = 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 16 hours after the start of Triferic administration on study Day 2 (IV infusion of 6 mg Triferic over 3 hours) and study day 3 (35 microgram/kg IV Triferic dose administered in 30 - 60 seconds) in order to determine the AUC(last) of total serum iron.
| Arm | Type | Description |
|---|---|---|
| Triferic AVNU infusion pre-dialyzer | EXPERIMENTAL | Patients will receive one (1) 6.75 mg Fe dose of Triferic AVNU by continuous infusion over 3 hours into the predialyzer blood line. |
| Triferic AVNU for injection at T=0 and T= 3 hours | EXPERIMENTAL | Patients will receive two (2) doses of Triferic AVNU 3.4 mg IV (2.25 mL) at T=0 and T=3 hours of hemodialysis into the venous drip chamber. |
| Triferic AVNU for injection at T=0 | EXPERIMENTAL | Patients will receive one (1) dose of Triferic AVNU 0.08 mg/kg IV, up to 6.75 mg Fe, at T=0 of hemodialysis into the venous drip chamber. |
| Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours | EXPERIMENTAL | Patients will receive three (3) doses of Triferic AVNU 2.25 mg Fe (1.5 mL) at T=0, T=1.5 and T=3.0 hours of hemodialysis into the venous drip chamber. |
| Triferic post-dialyzer; UFH via continuous infusion | EXPERIMENTAL | Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis. |
| UFH and Triferic admixture | EXPERIMENTAL | Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. |
| UFH via continuous infusion pre-dialyzer | EXPERIMENTAL | Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis |
| Triferic via Hemodialysate | EXPERIMENTAL | Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session. |
| Triferic via IV infusion( pre-dialyzer) | EXPERIMENTAL | Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via arterial blood line (pre-dialyzer) |
| Triferic via IV infusion (post-dialyzer) | EXPERIMENTAL | Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer) |
| single dose of Triferic in the peritoneal dialysis solution | EXPERIMENTAL | The patient will receive a single dose of Triferic in the peritoneal dialysis solution (IP) during a long (12 hour) peritoneal dialysis dwell. Each Cohort will receive a different ascending IP dose ( 5 mg/L, 12.5 mg/L, 20 mg/L). Blood samples will be drawn periodically over a 12 hour period for analysis. |
| single IV dose of Triferic 6.6 mg over a 4 hour period | EXPERIMENTAL | The patient will receive a single 6.6 mg intravenous (IV) dose of Triferic in the over a 4 hour period. All Cohorts will receive the same IV dose. Blood samples will be drawn periodically over a 12 hour period for analysis. |
| Triferic via IV infusion | EXPERIMENTAL | Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via the unused heparin infusion line (pre-dialyzer). Intervention: Drug: Triferic |
| Triferic IV infusion | EXPERIMENTAL | Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via an infusion port (post-dialyzer). Intervention: Drug: Triferic |
| Fer-In-Sol Orally | EXPERIMENTAL | Patients will receive A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw). |
| Shohl's solution followed by Fer-In-Sol Orally | EXPERIMENTAL | Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw. |
| Triferic Orally | EXPERIMENTAL | Patients will receive a single oral dose of Triferic at 3 mg Fe/kg bw. |
| Shohl's solution followed by Triferic Orally | EXPERIMENTAL | Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10 minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw. |
| Shohl's solution followed immediately by Triferic | EXPERIMENTAL | Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed immediately by a single oral dose of Triferic at 3 mg Fe/kg bw. |
| Triferic via IV | EXPERIMENTAL | Patients will receive IV Triferic iron 6.6 mg diluted in an appropriate amount of D5W administered as a 120 mL infusion intravenously for 4 hours. |
| Baseline | NO_INTERVENTION | baseline serum iron profile will be determined for each patient. no study drug will be administered. |
| Triferic via IV and Hemodialysate | EXPERIMENTAL | On study Day 1, patients will receive IV Triferic iron 0.07 mg/kg diluted in an appropriate amount of D5W administered as a 100 mL infusion into the venous return port of the blood lines during the time the patient is receiving dialysis.The rate of administration will be calculated as such that the entire amount will be administered over the course of the dialysis treatment. On study Day 3, Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic via the hemodialysate over the course of the dialysis treatment. |
| Treatment Period: 6 mg Triferic IV over 3 hours | EXPERIMENTAL | Each subject will receive a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours on Day 2. The Triferic IV dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 0.020 mg/mL. Administration of 300 mL IV at 100 mL/hr for 3 hours results in delivery of 6 mg of Triferic iron. |
| Treatment Period: 35 micrograms/kg IV push | EXPERIMENTAL | Each subject will receive Triferic as 35 µg/kg body weight IV push over 30-60 seconds on Day 3. The Triferic IV push dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 35 µg Triferic iron/kg body weight per subject in 4.5 mL. |
| Name | Type | Description |
|---|---|---|
| Triferic | DRUG | Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. |
| Heparin | DRUG | Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments. |
| Fer-In-Sol | DRUG | - |
| Shohl's solution | DRUG | - |
Inclusion Criteria: * Adult hemodialysis patients ≥18 years of age. * Signed informed consent to participate in the study. * Stable on hemodialysis prescription for ≥3 months. * Able to sustain hemodialysis 3x/week for 3 to 4 hours. * Hemoglobin concentration \>9.5 g/dL. * Serum TSAT ≥20%. * Receiv...
Triferic is an investigational small molecule being developed for nephrology conditions including End Stage Renal Disease, iron-refractory iron-deficiency anemia (IRIDA), and use in Peritoneal Dialysis (PD). It is being studied as a treatment to address iron deficiency and anemia in patients with chronic kidney disease.
Triferic is a form of ferric pyrophosphate citrate, an iron replacement agent. It delivers iron directly to the body to help maintain iron levels and support red blood cell production in patients with kidney disease who are undergoing dialysis.
Triferic is being developed by Rockwell Medical, Inc., a biopharmaceutical company focused on kidney disease treatments. Rockwell Medical is publicly traded on the Nasdaq under the ticker symbol RMTI.
Triferic is currently in Phase 1 clinical development. All six clinical trials listed for Triferic are Phase 1 studies, and all have been completed. Triferic remains investigational and has not been approved by the FDA.
Triferic has completed six Phase 1 trials, including NCT02739100, NCT02767128, NCT02909153, and NCT04042324. These studies evaluated Triferic administered via hemodialysate, intravenously, orally, and intraperitoneally in patients with End Stage Renal Disease, IRIDA, and Peritoneal Dialysis.
Yes, Triferic is also known as ferric pyrophosphate citrate. Clinical trial titles refer to Triferic as ferric pyrophosphate citrate, and the drug is being studied for its ability to deliver iron to patients with kidney disease.