Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney Disease
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
1 other identifier
observational
50
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2014
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 6, 2015
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 19, 2019
June 1, 2019
4.2 years
July 6, 2015
June 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
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.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Stanford University
Palo Alto, California, 94306, United States
Nemours Orlando A.I. DuPont Hospital for Children
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Linda M. Mundy, MD, PhD
American Regent, Inc.
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2015
First Posted
July 9, 2015
Study Start
September 1, 2014
Primary Completion
November 1, 2018
Study Completion
December 1, 2018
Last Updated
June 19, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share