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

Contrast Induced Nephropathy Clinical Trial

— CIN-RG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01456013
• Other study ID #: RGS001D
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: CardioRenal Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 326
• Est. completion date: December 2024
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Intervention

Device:
• RenalGuard Therapy
Induced Diuresis with matched replacement

Drug:
• Standard Therapy
Standard of care for patients at risk of CIN

Locations

Country	Name	City	State
United States	Austin Heart Central	Austin	Texas
United States	Johns Hopkins University	Baltimore	Maryland
United States	St. John Research Institute	Bartlesville	Oklahoma
United States	University of Alabama	Birmingham	Alabama
United States	St. Elizabeth's Hospital	Brighton	Massachusetts
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Clearwater Cardiovascular	Clearwater	Florida
United States	Advocate Good Samaritan	Downers Grove	Illinois
United States	Cape Cod Healthcare	Hyannis	Massachusetts
United States	University of Florida	Jacksonville	Florida
United States	Abbott Northwestern	Minneapolis	Minnesota
United States	Advocate Health	Naperville	Illinois
United States	Columbia University	New York	New York
United States	Montefiore Medical Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	NYU Medical Center	New York	New York
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Baylor Scott & White	Plano	Texas
United States	Rhode Island Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island
United States	Rex Hospital	Raleigh	North Carolina
United States	Austin Heart Round Rock	Round Rock	Texas
United States	St. Joseph Medical Center	Saint Charles	Missouri
United States	Guthrie Medical Center	Sayre	Pennsylvania
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Torrance Medical Center	Torrance	California
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Washington Hospital Center	Washington	District of Columbia
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CardioRenal Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Contrast Induced Nephropathy		72 hours
Secondary	Major Adverse Cardiac Events		90 days
Secondary	Mean peak increase in serum creatinine post contrast administration		72 hours
Secondary	Proportion of patients who develop CIN at 7 days post contrast administration		7 days
Secondary	Proportion of patients who maintain a rise in serum creatinine at 7 days		7 days