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

• Sponsor: CardioRenal Systems, Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01456013
• Collaborator: (none)
• Enrollment: 326
• Locations: 30
• Arms: 2
• Duration (Months): 84
• Patients Per Site: 10.9
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast Induced Nephropathy	Device: RenalGuard Therapy; Drug: Standard Therapy	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 326 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Mar 1, 2018
• Anticipated Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Incidence of Contrast Induced Nephropathy [72 hours]

Secondary Outcome Measures

1. Major Adverse Cardiac Events [90 days]

2. Mean peak increase in serum creatinine post contrast administration [72 hours]

3. Proportion of patients who develop CIN at 7 days post contrast administration [7 days]

4. Proportion of patients who maintain a rise in serum creatinine at 7 days [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35924
2	Torrance Medical Center	Torrance	California	United States	90505
3	Washington Hospital Center	Washington	District of Columbia	United States	20010
4	Clearwater Cardiovascular	Clearwater	Florida	United States	33756
5	University of Florida	Jacksonville	Florida	United States	32209
6	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
7	Advocate Good Samaritan	Downers Grove	Illinois	United States	60515
8	Advocate Health	Naperville	Illinois	United States	65040
9	Johns Hopkins University	Baltimore	Maryland	United States	21218
10	St. Elizabeth's Hospital	Brighton	Massachusetts	United States	02135
11	Cape Cod Healthcare	Hyannis	Massachusetts	United States	02601
12	University of Massachusetts	Worcester	Massachusetts	United States	01655
13	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
14	Abbott Northwestern	Minneapolis	Minnesota	United States	55407
15	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
16	St. Joseph Medical Center	Saint Charles	Missouri	United States	63301
17	NYU Medical Center	New York	New York	United States	10016
18	Mount Sinai Medical Center	New York	New York	United States	10029
19	Columbia University	New York	New York	United States	10032
20	Montefiore Medical Center	New York	New York	United States	10467
21	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
22	Rex Hospital	Raleigh	North Carolina	United States	27607
23	St. John Research Institute	Bartlesville	Oklahoma	United States	74006
24	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
25	Guthrie Medical Center	Sayre	Pennsylvania	United States	18840
26	Rhode Island Hospital	Providence	Rhode Island	United States	02903
27	The Miriam Hospital	Providence	Rhode Island	United States	02906
28	Austin Heart Central	Austin	Texas	United States	78756
29	Baylor Scott & White	Plano	Texas	United States	75093
30	Austin Heart Round Rock	Round Rock	Texas	United States	78681

Sponsors and Collaborators

• CardioRenal Systems, Inc.

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CardioRenal Systems, Inc.
• ClinicalTrials.gov Identifier: NCT01456013
• Other Study ID Numbers: RGS001D
• First Posted: Oct 20, 2011
• Last Update Posted: Dec 12, 2018
• Last Verified: Dec 1, 2018

• Additional relevant MeSH terms: Kidney Diseases

Study Results

No Results Posted as of Dec 12, 2018