Outcome Measures: |
Primary: Assess 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., 44 weeks | Secondary: Assess the ability of Triferic to maintain hemoglobin in pediatric CKD-5HD patients, Change from Baseline in hemoglobin concentration, 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, 44 weeks|Assess the change in reticulocyte hemoglobin content (CHr)., Change from Baseline in reticulocyte hemoglobin content (CHr)., 44 weeks
|
Locations: |
Loma Linda University Hospital, Loma Linda, California, 92354, United States|Childrens Hospital National Medical Center, Washington, District of Columbia, 20010, United States|Riley Hospital for Children at Indiana University, Indianapolis, Indiana, 46202, United States|Children's Mercy Hospital, Kansas City, Missouri, 64108, United States|Carolina's Medical Center, Charlotte, North Carolina, 28203, United States|Cincinnati Children's Hospital, Cincinnati, Ohio, 45229, United States|University of Texas Health Science Center At San Antonio, San Antonio, Texas, 78229, United States|Childrens Hospital and Medical Center- Seattle, Seattle, Washington, 98105, United States|University of Puerto Rico School of Medicine, San Juan, 00963-5067, Puerto Rico
|