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
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