Chronic Kidney Disease Clinical Trial
Official title:
A Multicenter Registry to Evaluate the Long-term Safety and Tolerability of Maintenance Treatment With Iron Sucrose (Venofer) in Pediatric Patients Ages ≥ 2 to ≤ 17 Years With Chronic Kidney Disease
The current registry is being undertaken to assess the long-term (12 month) safety and tolerability of Venofer in the pediatric population with chronic kidney disease that requires intravenous iron maintenance therapy.
This will be a multicenter, observational, prospective registry collecting long-term
(12-month) safety, tolerability, and laboratory data. Subjects will be screened for inclusion
criteria if on hemodialysis (HD), peritoneal dialysis (PD) or have non-dialysis dependent
(NDD) chronic kidney disease (CKD).
Treatment-emergent adverse events (adverse events starting from the time of the 1st dose of
Venofer administered on study) will be collected via site entry of data into a web-based
system. Each research investigator will be responsible for entering adverse event information
on the appropriate clinical research form as well as reporting such events to the sponsor.
Number of Subjects: 50 evaluable subjects (i.e., took at lease one dose of Venofer and have
safety data recorded at the 12 month time point).
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