Clinical trial NCT02492672: Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: 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).

Eligibility 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:

-

Primary outcomes:
measure: Treatment- emergent adverse events (TEAE)
timeFrame: 1st Venofer dose through 12 month observation
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Jacksonville
country: United States
facility: Nemours Orlando A.I. DuPont Hospital for Children
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: American Regent, Inc.
name: Linda M. Mundy, MD, PhD
role: STUDY_DIRECTOR
References: