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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02492672
Other study ID # Registry Protocol
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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:

-

Study Design


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
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