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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 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).
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment- emergent adverse events (TEAE) | Adverse Events starting from from the 1st dose of Venofer adminstered on study through 12 month observation | 1st Venofer dose through 12 month observation |
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Inclusion Criteria:
Exclusion Criteria:
-
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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 (CKD) that requries intravenous iron maintenance therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Linda M. Mundy, MD, PhD | American Regent, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94306 | United States | ||
| Nemours Orlando A.I. DuPont Hospital for Children |
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| Jacksonville |
| Florida |
| 32256 |
| United States |
| University of Miami | Miami | Florida | 33101 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Johns Hopkins Medicine | Baltimore | Maryland | 21205 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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