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

NCT01456013 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2023-02-16

No results posted yet for this study

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.

Conditions

  • Contrast Induced Nephropathy

Interventions

DEVICE

RenalGuard Therapy

Induced Diuresis with matched replacement

DRUG

Standard Therapy

Standard of care for patients at risk of CIN

Sponsors & Collaborators

  • CardioRenal Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Charles Davidson, MD · Northwestern University

  • Richard Solomon, MD · University of Vermont

  • Roxana Mehran, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2018-03-31
Completion
2024-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456013 on ClinicalTrials.gov