Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492672
• Other study ID #: Registry Protocol
• Status: Completed
• Start date: September 2014
• Est. completion date: December 2018

Study information

• Verified date: June 2019
• Source: American Regent, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	Johns Hopkins Medicine	Baltimore	Maryland
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	East Carolina University	Greenville	North Carolina
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Iowa	Iowa City	Iowa
United States	Nemours Orlando A.I. DuPont Hospital for Children	Jacksonville	Florida
United States	University of Miami	Miami	Florida
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
American Regent, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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