Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney Disease
- Conditions
- Chronic Kidney Disease
- Registration Number
- NCT02492672
- Lead Sponsor
- American Regent, Inc.
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment- emergent adverse events (TEAE) 1st Venofer dose through 12 month observation Adverse Events starting from from the 1st dose of Venofer adminstered on study through 12 month observation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
University of Miami
🇺🇸Miami, Florida, United States
Cincinnati Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Stanford University
🇺🇸Palo Alto, California, United States
Nemours Orlando A.I. DuPont Hospital for Children
🇺🇸Jacksonville, Florida, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Johns Hopkins Medicine
🇺🇸Baltimore, Maryland, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States