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



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Nephrology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:January 2012
End Date:January 2019

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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

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.


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.
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Hyannis, Massachusetts 02601
Principal Investigator: Richard Zelman, MD
Phone: 508-778-5900
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3400 N Charles St
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116th St and Broadway
New York, New York 10027
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Phone: 212-342-3486
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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1 Gustave L Levy Pl # 271
New York, New York 10029
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4200 Fifth Ave
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593 Eddy Street
Providence, Rhode Island 02903
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Principal Investigator: J. Dawn Abbott, MD, FACC, FSCAI
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3801 North Lamar Boulevard
Austin, Texas 78756
Principal Investigator: Mark Picone, MD
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816 South Keeler Avenue
Bartlesville, Oklahoma 74006
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Birmingham, Alabama 35294
Principal Investigator: Massoud Leesar, MD
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Brighton, Massachusetts 02135
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
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Clearwater, Florida 33756
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3815 Highland Avenue
Downers Grove, Illinois 60515
Principal Investigator: Mahesh Raju, MD
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Jacksonville, Florida 32209
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Minneapolis, Minnesota 55407
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Naperville, Illinois 65040
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New York, New York 10016
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New York, New York 10467
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Petoskey, Michigan 49770
Principal Investigator: Thomas J Earl
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4700 Alliance Boulevard
Plano, Texas 75093
Principal Investigator: Elizabeth Holper, MD
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164 Summit Ave
Providence, Rhode Island 02906
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Raleigh, North Carolina 27607
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2410 Round Rock Avenue
Round Rock, Texas 78681
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300 1st Capitol Drive
Saint Charles, Missouri 63301
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Sayre, Pennsylvania 18840
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101 Nicolls Rd
Stony Brook, New York 11794
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3330 Lomita Boulevard
Torrance, California 90505
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Tupelo, Mississippi 38801
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110 Irving St NW
Washington, District of Columbia 20010
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Worcester, Massachusetts 01655
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