NCT02492672

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Chronic Kidney Disease

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-11-01
• Completion: 2018-12-01
• First posted: 2015-07-09
• Last updated: 2019-06-19

Locations

9 sites across 1 country: United States