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

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 Overview

• Status: Completed
• Conditions: Chronic Kidney Disease

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).

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94306
      • Stanford University
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Nemours Orlando A.I. DuPont Hospital for Children
    • Miami, Florida, United States, 33101
      • University of Miami
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Medicine
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: American Regent, Inc.
• Investigators: Study Director: Linda M. Mundy, MD, PhD, American Regent, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: July 6, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: Registry Protocol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes