Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney Disease

American Regent

Status: Completed

Conditions: Chronic Kidney Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02492672

Registry Protocol

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria