The main purpose is to determine the safety of Triferic iron administered via dialysate and intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is a global, multi- center, open-label study.
This is a global, multi- center, multi dose, open-label study assessing the safety of Triferic iron administered via dialysate and intravenously to pediatric patients (\< 18 years of age) receiving chronic hemodialysis (CKD-5HD). Total participation in the study is approximately 44 weeks and is comprised of a screening visit, baseline, open label treatment, and a follow-up visit. Upon completion of the respective Baseline observational periods, all patients will transition to the interventional period where they will receive Triferic. The Triferic will be administered via the liquid bicarbonate or via IV. Once patients enter the interventional period, IV iron will only be administered if ferritin \<100 µg/L and Hgb decreases by ≥0.5g/dL from the last value obtained in the observational Baseline period. Patients will remain in the interventional period for either 36 or 28 weeks (depending on randomization assignment), at which time a final study visit will take place.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Ferric Pyrophosphate Citrate
Loma Linda University Hospital
Loma Linda, California, United States
RECRUITINGChildrens Hospital National Medical Center
Washington D.C., District of Columbia, United States
RECRUITINGAssess the incidence of adverse events of Triferic administration via dialysate and IV in pediatric CKD-5HD patients
Incidence and severity of adverse events compared to Baseline.
Time frame: 44 weeks
Assess the ability of Triferic to maintain hemoglobin in pediatric CKD-5HD patients
Change from Baseline in hemoglobin concentration
Time frame: 44 weeks
Assess the proportion of patients maintaining hemoglobin between 10.5-12.0 g/dL compared to baseline
Proportion of patients maintaining hemoglobin between 10.5 - 12.0 g/dL compared toBaseline
Time frame: 44 weeks
Assess the change in reticulocyte hemoglobin content (CHr).
Change from Baseline in reticulocyte hemoglobin content (CHr).
Time frame: 44 weeks
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Riley Hospital for Children at Indiana University
Indianapolis, Indiana, United States
RECRUITINGChildren's Mercy Hospital
Kansas City, Missouri, United States
RECRUITINGCarolina's Medical Center
Charlotte, North Carolina, United States
RECRUITINGCincinnati Children's Hospital
Cincinnati, Ohio, United States
RECRUITINGUniversity of Texas Health Science Center At San Antonio
San Antonio, Texas, United States
RECRUITINGChildrens Hospital and Medical Center- Seattle
Seattle, Washington, United States
RECRUITINGUniversity of Puerto Rico School of Medicine
San Juan, Puerto Rico
RECRUITING