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

CardioRenal Systems, Inc.30 sites in 1 country326 target enrollmentJanuary 2012

ConditionsContrast Induced Nephropathy

InterventionsStandard Therapy RenalGuard Therapy

DrugsStandard Therapy

Overview

Phase: Phase 3
Intervention: Standard Therapy
Conditions: Contrast Induced Nephropathy
Sponsor: CardioRenal Systems, Inc.
Enrollment: 326
Locations: 30
Primary Endpoint: Incidence of Contrast Induced Nephropathy
Status: Active, Not Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

December 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CardioRenal Systems, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or non-pregnant female equal or greater than the age of 18 years old and is able to provide informed consent.
•Subject is scheduled to undergo an elective catheterization procedure
•Hemodynamically stable
•At increased risk of developing CIN
•Subject has agreed to all follow-up testing.

Exclusion Criteria

•Class 4 Congestive Heart Failure (CHF)or a documented left ventricular ejection fraction \< 30%
•Is anuric or has undergone renal replacement therapy within the past month, or has a known inability to have a Foley catheter placed.
•Subject has been hospitalized or treated medically for any change in renal function over the past week (i.e. dialysis, etc.), or a significant change in renal function is noted at time of screening.
•Has documented severe Aortic Stenosis.(Note: Subjects who have undergone successful replacement or repair of their aortic valve are not excluded.)
•Currently has a known clinically significant electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
•Patient has severe anemia (hemoglobin \< 8.0 g/dL) at screening
•Has received contrast within 10 days of procedure or has a planned additional cardiac or renal or other major surgical procedure within the 7 day follow-up period.
•Has ruled in for a Serious Heart Attack within 48 hours of the planned procedure
•Has documented respiratory insufficiency as evidenced by an oxygen saturation of \< 90% on room air assessed on day of procedure.
•Planned addition, discontinuation or dose adjustment of nephrotoxic drugs

Arms & Interventions

Standard Therapy

Standard of care for patients at risk of CIN

Intervention: Standard Therapy

RenalGuard Therapy

Induced Diuresis with Matched Replacement

Intervention: RenalGuard Therapy

Outcomes

Primary Outcomes

Incidence of Contrast Induced Nephropathy

Time Frame: 72 hours

Secondary Outcomes

Major Adverse Cardiac Events(90 days)
Mean peak increase in serum creatinine post contrast administration(72 hours)
Proportion of patients who develop CIN at 7 days post contrast administration(7 days)
Proportion of patients who maintain a rise in serum creatinine at 7 days(7 days)