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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by PLC Medical Systems, Inc.
Sponsor:
Information provided by (Responsible Party):
PLC Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01456013
First received: October 18, 2011
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Contrast Induced Nephropathy
Device: RenalGuard Therapy
Drug: Standard Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Further study details as provided by PLC Medical Systems, Inc.:

Primary Outcome Measures:
  • Incidence of Contrast Induced Nephropathy [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major Adverse Cardiac Events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Mean peak increase in serum creatinine post contrast administration [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Proportion of patients who develop CIN at 7 days post contrast administration [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Proportion of patients who maintain a rise in serum creatinine at 7 days [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 326
Study Start Date: January 2012
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 3 or 4 Congestive Heart Failure (CHF)
  • 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 moderate to severe anemia (hematocrit < 27%) at screening
  • Has received contrast within 10 days of procedure or has a planned additional cardiac or renal or other major surgical procedure within the7 day follow-up period.
  • Has ruled in for an 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 the 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456013

Contacts
Contact: Andrew Halpert 508-541-8800 ahalpert@plcmed.com

Locations
United States, Connecticut
Hartford Hospital Terminated
Hartford, Connecticut, United States, 06106
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Hirity Shimellis         
Principal Investigator: Ron Waksman, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Katherine Jordan         
Principal Investigator: Charles Davidson, MD         
United States, Massachusetts
Brigham & Women's Hospital Terminated
Boston, Massachusetts, United States, 02115
St. Elizabeth's Hospital Recruiting
Brighton, Massachusetts, United States, 02135
Contact: Lindsay Pothier         
Principal Investigator: Joseph P Carrozza, MD         
Cape Cod Healthcare Recruiting
Hyannis, Massachusetts, United States, 02601
Contact: Carolyn Healy, RN, CCRC         
Principal Investigator: Richard Zelman, MD         
United States, Michigan
Beaumont Heart Center Withdrawn
Royal Oak, Michigan, United States, 48073
United States, Missouri
St. Joseph Medical Center Recruiting
St. Charles, Missouri, United States, 63301
Contact: Roxane Fisher, RN         
Principal Investigator: Mark D. Taber, MD         
United States, New York
NYU Medical Center Recruiting
New York, New York, United States, 10016
Contact: Dorcas Casaula, RN, BSN         
Principal Investigator: Cezar Staniloae, MD         
Mount Sinai Medical Center Recruiting
NY, New York, United States, 10029
Contact: Laura Ramirez         
Principal Investigator: George Dangas, MD, PhD         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Lynda Enden         
Principal Investigator: Luis Gruberg, MD, FACC         
United States, Pennsylvania
Allegheny General Hospital Withdrawn
Pittsburgh, Pennsylvania, United States, 15212
Guthrie Medical Center Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Kamie Hoey         
Principal Investigator: Daniel Sporn, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Maria Medeiros, RN         
Principal Investigator: J. Dawn Abbott, MD, FACC, FSCAI         
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Lori DeSimone, RN         
Principal Investigator: Paul Gordon, MD         
United States, Washington
Swedish Medical Center Withdrawn
Seattle, Washington, United States, 98122
Sponsors and Collaborators
PLC Medical Systems, Inc.
Investigators
Principal Investigator: Charles Davidson, MD Northwestern University
Principal Investigator: Richard Solomon, MD University of Vermont
Principal Investigator: Roxana Mehran, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: PLC Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01456013     History of Changes
Other Study ID Numbers: RGS001D
Study First Received: October 18, 2011
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014