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Study shows ferric pyrophosphate citrate can be successfully delivered via PD dialysate

DALLAS — A study shows that ferric pyrophosphate citrate administered via intraperitoneal delivery can successfully meet iron requirements for patients on PD.

Triferic (ferric pyrophosphate citrate, Rockwell Medical Inc.) is a water-soluble iron salt approved by the FDA to maintain iron balance and hemoglobin in patients receiving chronic hemodialysis. The research was aimed at determining whether it can also be used in PD.

“The inconvenience of giving intravenous (IV) iron has limited its use in [PD],” Raymond D. Pratt, MD, and colleagues wrote in an abstract presented at the Annual Dialysis Conference here. “Ferric pyrophosphate citrate (FPC) ... could be administered in peritoneal dialysis fluid (PDF) to replace and/or maintain iron stores.”

Thirty patients were enrolled in an open-label, randomized, two-period, single ascending dose study of ferric pyrophosphate citrate administered via PD dialysate. All patients received either 2 liters of dextrose (1.5%; Dianeal) or 1.5 liters of icodextrin (7.5%; Extraneal), for a 12-hour dwell. Ferric pyrophosphate citrate was administered with iron profile (Fe) concentrations of 2.5, 5 (two cohorts), 7.5 or 12.5 mg Fe/L. At another session, 6.5 mg of ferric pyrophosphate citrate was intravenously administered for 4 hours 

The researchers said iron absorption from the PD dialysate was dose dependent, “with peak [serum iron profile] at approximately 6 hours with return to baseline over the next ~8 hours. Clearance was similar to IV FPC administration.”

Ferric pyrophosphate citrate was well tolerated, the researchers said. Four patients (13%) experienced moderate abdominal discomfort and cramping on infusion of the 12.5-mg and 7.5-mg doses. Transient nausea and vomiting occurred in two patients (7%) upon infusion of PDF, and the subjects withdrew from the study.

“Ferric pyrophosphate citrate added to peritoneal dialysis fluid may be an effective and simple iron replacement therapy for PD patients,” the researchers wrote.

Reference:

Pratt R, et al. Single ascending dose study of intraperitoneal Triferic (ferric pyrophosphate citrate) in patients on chronic peritoneal dialysis. Presented at the Annual Dialysis Conference; March 16-19, 2019; Dallas.

 

Disclosures: Pratt is the chief medical officer for Rockwell Medical Inc. Other authors of the abstract have consulted for Rockwell.

 

DALLAS — A study shows that ferric pyrophosphate citrate administered via intraperitoneal delivery can successfully meet iron requirements for patients on PD.

Triferic (ferric pyrophosphate citrate, Rockwell Medical Inc.) is a water-soluble iron salt approved by the FDA to maintain iron balance and hemoglobin in patients receiving chronic hemodialysis. The research was aimed at determining whether it can also be used in PD.

“The inconvenience of giving intravenous (IV) iron has limited its use in [PD],” Raymond D. Pratt, MD, and colleagues wrote in an abstract presented at the Annual Dialysis Conference here. “Ferric pyrophosphate citrate (FPC) ... could be administered in peritoneal dialysis fluid (PDF) to replace and/or maintain iron stores.”

Thirty patients were enrolled in an open-label, randomized, two-period, single ascending dose study of ferric pyrophosphate citrate administered via PD dialysate. All patients received either 2 liters of dextrose (1.5%; Dianeal) or 1.5 liters of icodextrin (7.5%; Extraneal), for a 12-hour dwell. Ferric pyrophosphate citrate was administered with iron profile (Fe) concentrations of 2.5, 5 (two cohorts), 7.5 or 12.5 mg Fe/L. At another session, 6.5 mg of ferric pyrophosphate citrate was intravenously administered for 4 hours 

The researchers said iron absorption from the PD dialysate was dose dependent, “with peak [serum iron profile] at approximately 6 hours with return to baseline over the next ~8 hours. Clearance was similar to IV FPC administration.”

Ferric pyrophosphate citrate was well tolerated, the researchers said. Four patients (13%) experienced moderate abdominal discomfort and cramping on infusion of the 12.5-mg and 7.5-mg doses. Transient nausea and vomiting occurred in two patients (7%) upon infusion of PDF, and the subjects withdrew from the study.

“Ferric pyrophosphate citrate added to peritoneal dialysis fluid may be an effective and simple iron replacement therapy for PD patients,” the researchers wrote.

Reference:

Pratt R, et al. Single ascending dose study of intraperitoneal Triferic (ferric pyrophosphate citrate) in patients on chronic peritoneal dialysis. Presented at the Annual Dialysis Conference; March 16-19, 2019; Dallas.

 

Disclosures: Pratt is the chief medical officer for Rockwell Medical Inc. Other authors of the abstract have consulted for Rockwell.

 

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