Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease (The ALERT Study)
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
Roseville, Michigan 48066
Principal Investigator: Marjana Dimitrijevic, MD
Contact: Rosemarie Henschel @ 313.432.6273 or rhenschel@scsp.net
Minnesota
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