NCT01456013

Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients

A Study to Evaluate RenalGuard® System Safety & Efficacy When Compared With Standard Care in the Prevention of Contrast Induced NephRopathy in the SettinG of a Catheterization Laboratory

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: CardioRenal Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems undergo procedures that use iodinated contrast media, such as cardiac catheterizations. RenalGuard Therapy was developed to enable the patient to clear the contrast out of their kidney before it can do significant damage. This study aims to enroll patients with increased risk of developing CIN who are scheduled for a cardiovascular catheterization. Patients will be randomized to either RenalGuard therapy or standard therapy.

Conditions

• Contrast Induced Nephropathy

Interventions

Type	Name	Description
DEVICE	RenalGuard Therapy	Induced Diuresis with matched replacement
DRUG	Standard Therapy	Standard of care for patients at risk of CIN

Timeline

• Start date: 2012-01-01
• Primary completion: 2018-03-01
• Completion: 2024-12-01
• First posted: 2011-10-20
• Last updated: 2023-02-16

Locations

30 sites across 1 country: United States