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

Primary Purpose

Contrast Induced Nephropathy

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
RenalGuard Therapy
Standard Therapy
Sponsored by
CardioRenal Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama
  • Torrance Medical Center
  • Washington Hospital Center
  • Clearwater Cardiovascular
  • University of Florida
  • Northwestern Memorial Hospital
  • Advocate Good Samaritan
  • Advocate Health
  • Johns Hopkins University
  • St. Elizabeth's Hospital
  • Cape Cod Healthcare
  • University of Massachusetts
  • Northern Michigan Hospital
  • Abbott Northwestern
  • North Mississippi Medical Center
  • St. Joseph Medical Center
  • NYU Medical Center
  • Mount Sinai Medical Center
  • Columbia University
  • Montefiore Medical Center
  • Stony Brook University Medical Center
  • Rex Hospital
  • St. John Research Institute
  • University of Pittsburgh
  • Guthrie Medical Center
  • Rhode Island Hospital
  • The Miriam Hospital
  • Austin Heart Central
  • Baylor Scott & White
  • Austin Heart Round Rock

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Therapy

RenalGuard Therapy

Arm Description

Standard of care for patients at risk of CIN

Induced Diuresis with Matched Replacement

Outcomes

Primary Outcome Measures

Incidence of Contrast Induced Nephropathy

Secondary Outcome Measures

Major Adverse Cardiac Events
Mean peak increase in serum creatinine post contrast administration
Proportion of patients who develop CIN at 7 days post contrast administration
Proportion of patients who maintain a rise in serum creatinine at 7 days

Full Information

First Posted
October 18, 2011
Last Updated
February 15, 2023
Sponsor
CardioRenal Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01456013
Brief Title
Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardioRenal Systems, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Therapy
Arm Type
Active Comparator
Arm Description
Standard of care for patients at risk of CIN
Arm Title
RenalGuard Therapy
Arm Type
Experimental
Arm Description
Induced Diuresis with Matched Replacement
Intervention Type
Device
Intervention Name(s)
RenalGuard Therapy
Intervention Description
Induced Diuresis with matched replacement
Intervention Type
Drug
Intervention Name(s)
Standard Therapy
Intervention Description
Standard of care for patients at risk of CIN
Primary Outcome Measure Information:
Title
Incidence of Contrast Induced Nephropathy
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac Events
Time Frame
90 days
Title
Mean peak increase in serum creatinine post contrast administration
Time Frame
72 hours
Title
Proportion of patients who develop CIN at 7 days post contrast administration
Time Frame
7 days
Title
Proportion of patients who maintain a rise in serum creatinine at 7 days
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Davidson, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Solomon, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roxana Mehran, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35924
Country
United States
Facility Name
Torrance Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Clearwater Cardiovascular
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Advocate Good Samaritan
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Facility Name
Advocate Health
City
Naperville
State/Province
Illinois
ZIP/Postal Code
65040
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
St. Elizabeth's Hospital
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Cape Cod Healthcare
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Abbott Northwestern
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
St. Joseph Medical Center
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
NYU Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Montefiore Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
St. John Research Institute
City
Bartlesville
State/Province
Oklahoma
ZIP/Postal Code
74006
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Guthrie Medical Center
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Austin Heart Central
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Baylor Scott & White
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Austin Heart Round Rock
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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