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).
- Age greater than or equal to 2 to less than or equal to 17 years
- Subjects must have a diagnosis of either NDD-CKD, PD-CKD or HD-CKD
- Dialysis patients must be on a stable periotoneal (PD) or hemodialysis (HD) regimen
for 1 month
- Patient agrees to participate in the registry (i.e., provide adverse event
information) for 12 months