Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients (CIN-RG)
This study is currently recruiting participants.
Verified April 2013 by PLC Medical Systems, Inc.
Sponsor:
PLC Medical Systems, Inc.
Information provided by (Responsible Party):
PLC Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01456013
First received: October 18, 2011
Last updated: April 11, 2013
Last verified: April 2013
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456013
Contacts
| Contact: Susan Papalia, RN, BSN | 508-541-8800 | spapalia@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 | |
| St. Joseph Medical Center | Recruiting |
| St. Charles, Michigan, 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 | |
| Principal Investigator: Cezar Staniloae, MD | |
| Mount Sinai Medical Center | Recruiting |
| NY, New York, United States, 10029 | |
| Contact: Theresa Franklin-Bond, MS, PA-C | |
| Principal Investigator: Michael Kim, MD, FACC | |
| 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 | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Donna Creese | |
| Principal Investigator: Luis Ortega, MD | |
| 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: | April 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013