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

NCT ID: NCT01456013

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2024-12-31

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.

Conditions

Contrast Induced Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard Therapy

Standard of care for patients at risk of CIN

Group Type: ACTIVE_COMPARATOR

Standard Therapy

Intervention Type: DRUG

Standard of care for patients at risk of CIN

RenalGuard Therapy

Induced Diuresis with Matched Replacement

Group Type: EXPERIMENTAL

RenalGuard Therapy

Intervention Type: DEVICE

Induced Diuresis with matched replacement

Interventions

RenalGuard Therapy

Induced Diuresis with matched replacement

Intervention Type: DEVICE

Standard Therapy

Standard of care for patients at risk of CIN

Intervention Type: DRUG

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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioRenal Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Davidson, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Richard Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Roxana Mehran, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

University of Alabama

Birmingham, Alabama, United States

Torrance Medical Center

Torrance, California, United States

Washington Hospital Center

Washington D.C., 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

Cape Cod Healthcare

Hyannis, Massachusetts, United States

University of Massachusetts

Worcester, Massachusetts, United States

Northern Michigan Hospital

Petoskey, Michigan, United States

Abbott Northwestern

Minneapolis, Minnesota, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

St. Joseph Medical Center

Saint Charles, Missouri, United States

NYU Medical Center

New York, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Columbia University

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Rex Hospital

Raleigh, North Carolina, United States

St. John Research Institute

Bartlesville, Oklahoma, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Guthrie Medical Center

Sayre, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

The Miriam Hospital

Providence, Rhode Island, United States

Austin Heart Central

Austin, Texas, United States

Baylor Scott & White

Plano, Texas, United States

Austin Heart Round Rock

Round Rock, Texas, United States

Countries

United States

Other Identifiers

RGS001D

Identifier Type: -

Identifier Source: org_study_id