Abstract: SA-PO813
Pharmacokinetics of Ferric Pyrophosphate Citrate (Triferic®) in Pediatric CKD-5HD Patients
Session Information
- Dialysis: Anemia and Iron Metabolism
November 04, 2017 | Location: Hall H, Morial Convention Center
Abstract Time: 10:00 AM - 10:00 AM
Category: Dialysis
- 605 Dialysis: Anemia and Iron Metabolism
Authors
- Pratt, Raymond D., Rockwell Medical Inc, Wixom, Michigan, United States
- Gupta, Ajay, Rockwell Medical Inc, Wixom, Michigan, United States
Group or Team Name
- RMFPC-11 Study Group
Background
Triferic (FPC) is a carbohydrate-free complex iron salt with a MW ~1300 Daltons. FPC is approved as an iron replacement product to maintain hemoglobin in adult patients receiving chronic hemodialysis. Triferic rapidly transfers across the dialyzer membrane, donates iron directly to transferrin, and is cleared from the circulation with a half-life of 2 to 4 hr. The current study examined the pharmacokinetics (PK) of Triferic administered via dialysate and intravenously (IV) to pediatric hemodialysis patients.
Methods
This was an open-label, two period single dose study conducted in 22 CKD-5HD patients between ages 1 and 17 years. Each patient received 2 treatments in sequential order. Blood was drawn for serum iron profile at defined times for PK analysis. The treatments were Triferic 0.07 mg Fe/kg IV into the post-dialyzer blood line (FPC-IV) and Triferic 2 mM (110 mg Fe/L) via HD (FPC-HD). HD was conducted for 3-4 hours and IV infusions were administered during HD. An estimate of iron delivered at the dialysis session was calculated by using partial AUC based on the IV dose.
Results
A total of 22 subjects, age range 1-17 years were enrolled. PK data are available on 21 subjects. There was greater inter-individual variability and lower peak iron levels in the younger age group patients. FPC-HD showed a similar intradialytic and post-dialysis iron profile as FPC-IV in all age groups. The results of mean intradialytic change in serum Fe with HD and IV, and average dose administered via HD (Fe HD) are presented below:
Non-compartmental analysis showed that FPC was rapidly cleared with a t½ of approximately 2 hr. FPC was well tolerated with no drug related adverse effects noted.
Conclusion
This study shows that FPC iron can be delivered to pediatric CKD5HD patients either intravenously when using solid bicarbonate cartridge or bag system, or via the dialysate. FPC was well tolerated. The results suggest that IV administration in patients below age 12 be started at 0.1 mg Fe/kg and increased as needed to achieve a post HD target TSAT of around 75%.
Iron Parameters after FPC via Dialysate or IV
| Age yr. | N | ΔsFe HD μg/dL (SD) | ΔTSAT % | TSATMax % | Fe HD Dose mg | Fe HD Dose mg/kg | TSATmax IV |
| 1-5 | 3 | 55.5 (26.2) | 17.3 | 34.3 | 1.47 | 0.08 | 34.7 |
| 6-11 | 2 | 73.5 (9.2) | 25.3 | 52.5 | 1.67 | 0.06 | 43.8 |
| 12-17 | 16 | 189.9 (58.5) | 59.1 | 87.3 | 4.97 | 0.09 | 61.6 |
Funding
- Commercial Support – Rockwell Medical Inc.