Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0790
Source ID: NCT04239391
Associated Drug: Triferic
Title: Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC)
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: End Stage Renal Disease
Interventions: DRUG: Triferic
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
Sponsor/Collaborators: Sponsor: Rockwell Medical Technologies, Inc.
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 150
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-09-01
Completion Date: 2023-11-01
Results First Posted:
Last Update Posted: 2021-04-21
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
URL: https://clinicaltrials.gov/show/NCT04239391