Triferic (soluble ferric pyrophosphate) / Rockwell Medical - LARVOL DELTA

Evaluation of Bacteriology of Bicarbonate Dialysis Solution (BDS) From Hemodialysis (HD) Clinics That Have Adopted Ferric Pyrophosphate Citrate (FPC; Triferic ) (KIDNEY WEEK 2022) - "2021;4(11):e2133935. Water Analysis Reports' Results"

Chronic Kidney Disease • Infectious Disease • Renal Disease

Ethnicity evaluation of ferric pyrophosphate citrate among Asian and Non-Asian populations: a population pharmacokinetics analysis. (PubMed, Eur J Clin Pharmacol) - "The population pharmacokinetics model successfully described the PK parameters of FPC in healthy subjects and CKD-5HD patients and were comparable between Asian and non-Asian populations."

Journal • PK/PD data • Chronic Kidney Disease • Nephrology • Renal Disease

"$RMTI Rockwell Medical Announces Regulatory Approval of Triferic® Dialysate in South Korea https://t.co/iODqE8TQHK" (@stock_titan)

Pharmacokinetics and Safety of Ferric Pyrophosphate Citrate Intravenous: Equivalence to Administration via Dialysate. (PubMed, J Clin Pharmacol) - "Intravenous infusion of 6.75 mg iron as FPC during 3 hours of HD delivers an equivalent amount of iron as when Triferic is delivered via hemodialysate...Intravenous infusion of 6.75 mg iron as FPC during 3 hours of HD delivers an equivalent amount of iron as when Triferic is delivered via hemodialysate. The intravenous presentation of FPC extends the ability to provide FPC iron to all patients receiving hemodialysis or hemodiafiltration."

Clinical • Journal • PK/PD data • Renal Disease

[VIRTUAL] Triferic (Ferric Pyrophosphate Citrate, FPC) Maintains Hemoglobin and Reduces Total IV Iron Requirement: Results from a Mid-Sized Dialysis Organization (MDO) Pilot Observational Analysis (KIDNEY WEEK 2021) - "Concurrent with these changes Mircera® (-epoetin beta) dose remained stable in the SoC group but was reduced 37% (from post-adoption baseline) in the new group. This observational study demonstrates that FPC is a well tolerated replacement for IV Fe when administered to all patients in a HD unit. The findings of this real-world observational study align with pivotal clinical trials and previously reported real-world evidence in terms of reduction of IV Fe use and maintenance of Hb."

Anemia • Hematological Disorders

"$RMTI Rockwell Medical Announces Marketing Approval of Triferic® AVNU™ in Canada https://t.co/jJK5nzh5Jw" (@stock_titan)

Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus. (clinicaltrials.gov) - P1/2; N=23; Active, not recruiting; Sponsor: Rockwell Medical Technologies, Inc.; Recruiting ➔ Active, not recruiting; N=12 ➔ 23; Trial completion date: Dec 2020 ➔ Aug 2021; Trial primary completion date: Dec 2020 ➔ May 2021

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

Triferic AVNU Infusion Via Freedom Pump During Hemodialysis (clinicaltrials.gov) - P4; N=12; Recruiting; Sponsor: Rockwell Medical Technologies, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

"$RMTI Rockwell Medical Announces U.S. Availability of Triferic® AVNU for Replacement of Iron and Maintenance of Hemoglobin in Patients on Hemodialysis https://t.co/xfU7LwhXsr" (@stock_titan)

Clinical

Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC) (clinicaltrials.gov) - P3; N=150; Recruiting; Sponsor: Rockwell Medical Technologies, Inc.; Trial completion date: Sep 2022 ➔ Nov 2023; Trial primary completion date: Aug 2022 ➔ Aug 2023

Clinical • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Hematological Disorders • Nephrology • Pediatrics • Renal Disease

Triferic AVNU Infusion Via Freedom Pump During Hemodialysis (clinicaltrials.gov) - P4; N=12; Not yet recruiting; Sponsor: Rockwell Medical Technologies, Inc.; Trial completion date: Feb 2021 ➔ Jun 2021

Trial completion date • Chronic Kidney Disease • Nephrology • Renal Disease

Rockwell Medical Announces Dosing of First Patient in Pivotal Triferic Phase 3 Trial by Partner, Wanbang Biopharmaceuticals, in China (GlobeNewswire) - "Rockwell Medical...today announced that its partner in China, Wanbang Biopharmaceuticals...enrolled the first patient in a pivotal Phase 3 trial for Triferic Dialysate to support a new drug application for regulatory approval in that country."

Enrollment status • Renal Disease

Triferic AVNU Infusion Via Freedom Pump During Hemodialysis (clinicaltrials.gov) - P4; N=12; Not yet recruiting; Sponsor: Rockwell Medical Technologies, Inc.

New P4 trial • Chronic Kidney Disease • Nephrology • Renal Disease

A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients (clinicaltrials.gov) - P1/2; N=12; Completed; Sponsor: Rockwell Medical Technologies, Inc.; Not yet recruiting ➔ Completed; Trial completion date: Sep 2019 ➔ Jan 2020; Trial primary completion date: Sep 2019 ➔ Jan 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

[VIRTUAL] Minimize Risk of Iron Overload: Centralize Delivery With a Novel Approach to Anemia Management in Hemodialysis (KIDNEY WEEK 2020) - "Log on to join a panel of experts who will discuss the current targets for anemia management and the place in therapy for TRIFERIC® (ferric pyrophosphate citrate)...Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation. Adverse ReactionsMost common adverse reactions (incidence ≥3% and at least 1% greater than placebo) in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspne"

Anemia • Back Pain • Cardiovascular • Chronic Kidney Disease • Fatigue • Hematological Disorders • Hypotension • Immunology • Infectious Disease • Musculoskeletal Pain • Nephrology • Pain • Renal Disease • Thrombosis

[VIRTUAL] Use of Triferic and Outcomes of Hemodialysis-Dependent Patients: Initial Analysis Using 2016-2017 USRDS (KIDNEY WEEK 2020) - "This observational cohort study suggests that use of ferric pyrophosphate citrate as an iron replacement therapy is associated with reduction in all cause and infection-related hospitalizations and mortality. Further analysis is needed to confirm the findings from this initial analysis after controlling a variety of patient case-mix factors and dialysis center characteristics with a larger sample size. Funding: Commercial Support"

Clinical • Chronic Kidney Disease • Renal Disease

[VIRTUAL] Triferic (Ferric Pyrophosphate Citrate, FPC) Maintains Hemoglobin and Reduces IV Iron: Results from a Single-Site 2-Year Observational Analysis (KIDNEY WEEK 2020) - "During the first 4 months of FPC, the center converted pts from epoetin alfa (EPO) to darbepoetin alfa (INN), therefore INN equivalents were calculated using the published conversion guide (EPO dose/300). This observational study demonstrates that FPC is a well tolerated replacement for IV Fe when administered to all patients in a HD unit. The findings of this real-world observational study align with those of clinical trials in terms of reduction of IV Fe use and maintenance of Hgb. ESA was gradually reduced and the KDQoL showed a trend to improvement in the burden and symptoms of kidney disease."

Hematological Disorders • Nephrology • Renal Disease

Triferic IRIDA Protocol (clinicaltrials.gov) - P2; N=1; Terminated; Sponsor: Rockwell Medical Technologies, Inc.; N=28 ➔ 1; Completed ➔ Terminated; Limited subjects, patient compliance

Clinical • Enrollment change • Trial termination • Anemia • Hematological Disorders

Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC) (clinicaltrials.gov) - P3; N=150; Recruiting; Sponsor: Rockwell Medical Technologies, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Jan 2020 ➔ Jun 2020

Clinical • Enrollment open • Trial initiation date • Chronic Kidney Disease • Hematological Disorders • Nephrology • Pediatrics • Renal Disease

Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus. (clinicaltrials.gov) - P1/2; N=12; Recruiting; Sponsor: Rockwell Medical Technologies, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Nephrology • Renal Disease

A Randomized 4 Period Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus. (clinicaltrials.gov) - P1/2; N=12; Not yet recruiting; Sponsor: Rockwell Medical Technologies, Inc.

Clinical • New P1/2 trial • Nephrology • Renal Disease

"In the spirit of @bradloncar, I put together a chart to visualize $RMTI Triferic sales since approval in January 2015. I hope this helps." - adamfeuerstein

Biosimilar

"Triferic AVNU Approved for Iron Replacement and Hemoglobin Maintenance in Dialysis Patients https://t.co/qVgZ7KAamq" (@kamkalantar)

Clinical

Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC) (clinicaltrials.gov) - P3; N=150; Not yet recruiting; Sponsor: Rockwell Medical Technologies, Inc.

Clinical • New P3 trial

Pharmacokinetics of ferric pyrophosphate citrate administered via dialysate and intravenously to pediatric patients on chronic hemodialysis. (PubMed, Pediatr Nephrol) - "FPC iron can be administered to pediatric patients with CKD-5HD via dialysate or by the IV route. Further study of FPC administered to maintain hemoglobin concentration is indicated."

Clinical • Journal • PK/PD data