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

NCT01456013 | Unknown Phase 3 DMC

• 1 other identifier: RGS001D
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 30

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Contrast Induced Nephropathy

  72 hours

Secondary Outcomes (4)

• 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

Study Arms (2)

Standard Therapy

ACTIVE COMPARATOR

Standard of care for patients at risk of CIN

Drug: Standard Therapy

RenalGuard Therapy

EXPERIMENTAL

Induced Diuresis with Matched Replacement

Device: RenalGuard Therapy

Interventions

RenalGuard Therapy DEVICE

Induced Diuresis with matched replacement

RenalGuard Therapy

Standard Therapy DRUG

Standard of care for patients at risk of CIN

Standard Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CardioRenal Systems, Inc.: lead

Study Sites (30)

University of Alabama

Birmingham, Alabama, 35924, United States

Location

Torrance Medical Center

Torrance, California, 90505, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Clearwater Cardiovascular

Clearwater, Florida, 33756, United States

Location

University of Florida

Jacksonville, Florida, 32209, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Advocate Good Samaritan

Downers Grove, Illinois, 60515, United States

Location

Advocate Health

Naperville, Illinois, 65040, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

St. Elizabeth's Hospital

Brighton, Massachusetts, 02135, United States

Location

Cape Cod Healthcare

Hyannis, Massachusetts, 02601, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

Abbott Northwestern

Minneapolis, Minnesota, 55407, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Joseph Medical Center

Saint Charles, Missouri, 63301, United States

Location

NYU Medical Center

New York, New York, 10016, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

St. John Research Institute

Bartlesville, Oklahoma, 74006, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Guthrie Medical Center

Sayre, Pennsylvania, 18840, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Austin Heart Central

Austin, Texas, 78756, United States

Location

Baylor Scott & White

Plano, Texas, 75093, United States

Location

Austin Heart Round Rock

Round Rock, Texas, 78681, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Charles Davidson, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Richard Solomon, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

• Roxana Mehran, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: October 20, 2011
• Study Start: January 1, 2012
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2024
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

US (30)