Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease (The ALERT Study)

Multiple Locations

Overview

 

The ALERT Study is a Phase 3 clinical trial designed for those who have previously taken JYNARQUE® (tolvaptan) for their ADPKD, and experienced abnormal liver chemistry tests as a result.

The ALERT Study is an open-label (no placebo) study, designed to find out how safe the study drug, lixivaptan, is for ADPKD patients like you. Lixivaptan functions similarly to the way tolvaptan does in patients with ADPKD, and has been shown in previous animal and human studies to be generally safe and well-tolerated with no reported negative effects on the liver. Enrolled participants will be asked to come to approximately 27 visits for about 73 weeks or 16 months. Where available, some visits may be conducted at home or at an alternative location.

 

You may be able to participate if you:

  • Are between the ages 18-65  at the time of screening
  • Have a confirmed diagnosis of ADPKD by imaging or genetic (DNA) analysis and have been previously treated with JYNARQUE® (tolvaptan) for that diagnosis
  • Permanently stopped taking JYNARQUE® (tolvaptan) because of abnormal liver chemistry test results while on it

Other eligibility criteria will apply

 

Study drug and assessments will be provided at no cost. Reimbursements for reasonable study related expenses, may be provided.

 

If you’d like to find out more, click here and answer a couple of questions to see if you qualify for the study!

 

Locations:

 

Alabama

University of Alabama at Birmingham

Birmingham, AL 35233

Principal Investigator:  Michal Mrug, MD

Contact: Amy Bottomlee @ amybottomlee@uabmc.edu

 

California

University of California Los Angeles

Los Angeles, CA 90025

Principal Investigator: Anjay Rastogi, MD, PhD

Contact: XiaoXiao Yin @ xiaoxiaoyin@mednet.ucla.edu

 

Illinois

University of Chicago Medicine and Biological Sciences

Chicago, IL 60637

Principal Investigator: Arlene Chapman, MD

Contact: Serdar Aydin, MD @ serdarmd@medicine.bsd.uchicago.edu

 

Maryland

University of Maryland School of Medicine

Baltimore, MD 21201

Principal Investigator: Stephen Seliger, MD

Contact: Charalett Diggs @ charalett.diggs@som.umaryland.edu

 

Michigan

St. Clair Nephrology

Roseville, Michigan 48066

Principal Investigator: Marjana Dimitrijevic, MD

Contact: Rosemarie Henschel @ 313.432.6273 or rhenschel@scsp.net

 

Minnesota

Mayo Clinic

Rochester, MN 55905

Principal Investigator: Vicente Torres, MD PhD

Contact: Kathleen Leistikow @ leistikow.kathleen@mayo.edu

 

North Carolina

Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina 27103

Principal Investigator: Gregory Greenwood, MD

 

Pennsylvania

Northeast Clinical Research Center, LLC

Bethlehem, Pennsylvania 18107

Principal Investigator: Nelson Kopyt, MD

 

Virginia

Nephrology Associates of Northern Virginia

Fairfax, Virginia 22033

Principal Investigator: Amadshah Mirkhel, MD