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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Contrast Induced Nephropathy
• Intervention / Treatment: Drug: Standard Therapy; Device: RenalGuard Therapy

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35924
      • University of Alabama
  • California
    • Torrance, California, United States, 90505
      • Torrance Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular
    • Jacksonville, Florida, United States, 32209
      • University of Florida
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Downers Grove, Illinois, United States, 60515
      • Advocate Good Samaritan
    • Naperville, Illinois, United States, 65040
      • Advocate Health
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • St. Elizabeth's Hospital
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Healthcare
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • Michigan
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Saint Charles, Missouri, United States, 63301
      • St. Joseph Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • New York, New York, United States, 10016
      • NYU Medical Center
    • New York, New York, United States, 10467
      • Montefiore Medical Center
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Rex Hospital
  • Oklahoma
    • Bartlesville, Oklahoma, United States, 74006
      • St. John Research Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart Central
    • Plano, Texas, United States, 75093
      • Baylor Scott & White
    • Round Rock, Texas, United States, 78681
      • Austin Heart Round Rock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Therapy; Standard of care for patients at risk of CIN	Drug: Standard Therapy; Standard of care for patients at risk of CIN
Experimental: RenalGuard Therapy; Induced Diuresis with Matched Replacement	Device: RenalGuard Therapy; Induced Diuresis with matched replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Contrast Induced Nephropathy	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: CardioRenal Systems, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): March 1, 2018
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 18, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: RGS001D