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

Completed

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT02492672

Run by

American Regent, Inc.

People needed

50

Starts

2014-09-01

Expected to finish

2018-12-01

Last updated by the study team

2019-06-19

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Stanford University — Palo Alto, California, United States
• Nemours Orlando A.I. DuPont Hospital for Children — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins Medicine — Baltimore, Maryland, United States
• East Carolina University — Greenville, North Carolina, United States
• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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