Cincinnati, Ohio 45229


Purpose:

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.


Study summary:

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).


Criteria:

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:


NCT ID:

NCT02492672


Primary Contact:

Study Director
Linda M. Mundy, MD, PhD
Luitpold Pharmaceuticals

Angelia Butcher
Phone: 610-650-4200


Backup Contact:

Email: SChowdhury@lpicrd.com
Sumita Chowdhury, MD, MPH
Phone: 610-650-4200


Location Contact:

Cincinnati, Ohio 45229
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.