Chronic Kidney Disease Clinical Trial
Official title:
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
Verified date | June 2019 |
Source | American Regent, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2018 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 17 Years |
Eligibility |
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: - |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Medicine | Baltimore | Maryland |
United States | Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | East Carolina University | Greenville | North Carolina |
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | University of Iowa | Iowa City | Iowa |
United States | Nemours Orlando A.I. DuPont Hospital for Children | Jacksonville | Florida |
United States | University of Miami | Miami | Florida |
United States | Stanford University | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
American Regent, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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