| Outcome Measures: |
Primary: Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: Cmax., 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., 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hrs|Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(Last)., 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., 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours|Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(0-end)., 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., 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours | Secondary: Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: Cmax., The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron. 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., 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours|Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(Last)., The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron. The absolute AUC (last) includes the 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., 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours|Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(0-end)., The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron. The absolute AUC (0-end) includes the 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., 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours | Other: Treatment-emergent Adverse Events (TEAEs), The incidence of treatment-emergent AEs (TEAEs) and treatment-emergent serious AEs (TESAEs) will be grouped by body system. Adverse events were recorded from study Day 1 through the following up visit (approximately 1.5 weeks)., 1.5 weeks
|
| Locations: |
Children's Hospital of Alabama, Birmingham, Alabama, 35233, United States|Loma Linda University Hospital, Loma Linda, California, 92354, United States|Lucile Packard Childrens Hospital, Stanford, California, 94305, United States|Nemours/A. I. DuPont Hospital for Children, Wilmington, Delaware, 19803, United States|Joe DiMagggio Children's Hospital/Memorial Regional Hospital, Hollywood, Florida, 33021, United States|Jackson Memorial Hospital, Miami, Florida, 33136, United States|Childrens Mercy Hospital, Kansas City, Missouri, 64108, United States|Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio, 45229, United States|University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States
|
