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

Phase 3

Active, not recruiting

• Conditions: Contrast Induced Nephropathy
• Interventions: Device: RenalGuard Therapy; Drug: Standard Therapy

• Registration Number: NCT01456013
• Lead Sponsor: CardioRenal Systems, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-20
• Study Start: 2012-01
• Primary Completion: 2018-03
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 326

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
• Subject has a known hypersensitivity to furosemide and/or the contrast agent being used.
• Subject is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days.
• Subject is pregnant or breastfeeding.
• Subject is unable to provide informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RenalGuard Therapy	RenalGuard Therapy	Induced Diuresis with Matched Replacement
Standard Therapy	Standard Therapy	Standard of care for patients at risk of CIN

Primary Outcome Measures

Name	Time	Method
Incidence of Contrast Induced Nephropathy	72 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (30)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Torrance Medical Center; 🇺🇸 Torrance, California, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Clearwater Cardiovascular; 🇺🇸 Clearwater, Florida, United States

University of Florida; 🇺🇸 Jacksonville, Florida, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Advocate Good Samaritan; 🇺🇸 Downers Grove, Illinois, United States

Advocate Health; 🇺🇸 Naperville, Illinois, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

St. Elizabeth's Hospital; 🇺🇸 Brighton, Massachusetts, United States

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