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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01456013
Recruitment Status : Active, not recruiting
First Posted : October 20, 2011
Last Update Posted : April 4, 2018
Information provided by (Responsible Party):
PLC Medical Systems, Inc.

October 18, 2011
October 20, 2011
April 4, 2018
January 2012
May 2018   (Final data collection date for primary outcome measure)
Incidence of Contrast Induced Nephropathy [ Time Frame: 72 hours ]
Same as current
Complete list of historical versions of study NCT01456013 on Archive Site
  • Major Adverse Cardiac Events [ Time Frame: 90 days ]
  • Mean peak increase in serum creatinine post contrast administration [ Time Frame: 72 hours ]
  • Proportion of patients who develop CIN at 7 days post contrast administration [ Time Frame: 7 days ]
  • Proportion of patients who maintain a rise in serum creatinine at 7 days [ Time Frame: 7 days ]
Same as current
Not Provided
Not Provided
Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Contrast Induced Nephropathy
  • Device: RenalGuard Therapy
    Induced Diuresis with matched replacement
  • Drug: Standard Therapy
    Standard of care for patients at risk of CIN
  • Active Comparator: Standard Therapy
    Standard of care for patients at risk of CIN
    Intervention: Drug: Standard Therapy
  • Experimental: RenalGuard Therapy
    Induced Diuresis with Matched Replacement
    Intervention: Device: RenalGuard Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
June 2018
May 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
PLC Medical Systems, Inc.
PLC Medical Systems, Inc.
Not Provided
Principal Investigator: 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
PLC Medical Systems, Inc.
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP