• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » First patient treated in PLC Systems' RenalGuard U.S. trial

First patient treated in PLC Systems' RenalGuard U.S. trial

January 23, 2012
CenterWatch Staff

PLC Systems, focused on innovative medical device technologies, has successfully enrolled the first patient in the CIN-RG trial, its pivotal trial to study the efficacy of its RenalGuard therapy and RenalGuard system in the prevention of Contrast-Induced Nephropathy (CIN).

"RenalGuard offers us the potential for a method to reduce the incidence of CIN while allowing me as an interventional cardiologist to focus on the catheterization without having to worry that the contrast may be damaging the patient's kidney," said Dr. Michael Kim, director of the Coronary Care Unit at Mount Sinai Hospital, who enrolled the first patient.

The study is designed as an adaptive, randomized, controlled trial at up to 30 sites in the U.S. Enrollment will include at least 326 patients and potentially up to 652 patients, depending upon the outcome of a sample size re-estimation after 163 patients. The re-estimation enables investigators to ensure the trial is sufficiently powered so the final results are statistically meaningful.

"Using lessons learned from the clinical trials of RenalGuard in Europe, as well as other clinical developments since 2008, we made slight modifications to our original trial protocol that we believe will make it more robust,” said Mark R. Tauscher, president and CEO of PLC.

PLC's U.S. study builds upon two clinical trials by independent clinical investigators in Europe, both of which showed significant reductions in incident rates of CIN in at-risk patients through the use of RenalGuard compared to the current standard of care.

Upcoming Events

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • tablet

    Digital Intake Platforms Effective as Source of Trial Information, Survey Shows

  • Diversity-360x240.png

    Site Spotlight: EmVenio Research Takes to the Road to Promote Trial Diversity

  • Five Ws

    Consider the Five ‘W’s to Understand Potential Participants

  • QandA-360x240.png

    Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing