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.
Brief Title
Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Contrast Induced Nephropathy
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01456013
Org Class
Industry
Org Full Name
CardioRenal Systems, Inc.
Org Study Id
RGS001D
Overall Status
Unknown status
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Measure
Incidence of Contrast Induced Nephropathy
Outcome Time Frame
72 hours
Secondary Outcomes
Outcome Time Frame
90 days
Outcome Measure
Major Adverse Cardiac Events
Outcome Time Frame
72 hours
Outcome Measure
Mean peak increase in serum creatinine post contrast administration
Outcome Time Frame
7 days
Outcome Measure
Proportion of patients who develop CIN at 7 days post contrast administration
Outcome Time Frame
7 days
Outcome Measure
Proportion of patients who maintain a rise in serum creatinine at 7 days
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Giora Weisz
Investigator Email
gweisz@montefiore.org
Investigator Phone