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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02492672

Enrollment

Registered

2015-07-09

Start date

2014-09-30

Completion date

2018-12-31

Last updated

2019-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

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).

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Treatment- emergent adverse events (TEAE)	1st Venofer dose through 12 month observation	Adverse Events starting from from the 1st dose of Venofer adminstered on study through 12 month observation

Countries

United States

Outcome results