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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by PLC Medical Systems, Inc.
Sponsor:
Information provided by (Responsible Party):
PLC Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01456013
First received: October 18, 2011
Last updated: June 2, 2017
Last verified: June 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by PLC Medical Systems, Inc.:

Primary Outcome Measures:
  • Incidence of Contrast Induced Nephropathy [ Time Frame: 72 hours ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 326
Study Start Date: January 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456013

Contacts
Contact: Andrew Halpert 508-520-2530 ahalpert@renalguard.com

  Show 24 Study Locations
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 Icahn School of Medicine at Mount Sinai
  More Information

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: June 2, 2017

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 22, 2017