Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney Disease
Status: | Active, not recruiting |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 2 - 17 |
Updated: | 11/30/2018 |
Start Date: | September 2014 |
End Date: | December 2018 |
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
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.
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).
(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).
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:
We found this trial at
9
sites
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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University of Miami A private research university with more than 15,000 students from around the...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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