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ELiSA, a Phase 2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Lixivaptan in Subjects with Autosomal Dominant Polycystic Disease

This study will look at how well two different doses of lixivaptan work in preserving kidney function. It will also look at how well adult subjects with ADPKD tolerate the study drug, which will be given by mouth twice per day for seven days. Blood and urine samples will be taken to evaluate what happens to the study drug in the body, for example how long it remains in the blood and how quickly it is removed, as well as to examine possible other measures such as liver function tests and urine concentration.

Study participants must be able to stay overnight at the clinical research unit on two separate occasions. Participants will be eligible to receive a stipend as well as reimbursement for travel and certain other expenses for themselves and a companion. Additional details will be provided by the clinical study site.


Drug:  Lixivaptan

Participant Information

Inclusion Criteria:

  • Male or female, between 18 and 65 years of age
  • Diagnosed with ADPKD by modified Ravine criteria
  • CKD Stages 1, 2, or 3
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2
  • Considered by Investigator to be in good health relative to underlying CKD status and clinically stable with respect to underlying CKD

Exclusion Criteria:

ADPKD patients cannot participate in the study if they:

  • Have had an allergic or bad reaction (known sensitivity or idiosyncratic reaction) to lixivaptan or its related compounds, such as benzazepines (e.g., tolvaptan, conivaptan, benazepril, fenoldopam, or mirtazapine)
  • Are pregnant or breastfeeding
  • Have taken tolvaptan, oral or intravenous antibiotics, or any investigational drug or used an investigational device within 30 days prior to first study dose
  • Have a transplanted kidney, or absence of a kidney
  • Have clinically significant incontinence, overactive bladder, or urinary retention (for example, benign prostatic hyperplasia)
  • Have clinically significant liver disease, or clinically significant liver function abnormalities other than that expected for ADPKD with cystic liver disease at baseline
  • Have any other clinically significant disease or condition in addition to ADPKD (including treatment for such conditions) that, in the opinion of the Investigator, could either interfere with the study drug or pose an unacceptable risk to the subject

Studies being conducted in California, Florida, Kansas, Maryland, Minnesota, Missouri, New York, Pennsylvania, Tennessee, Utah.

Age Range: 18 to 65 years

Stage:  Recruiting

Status:  Active

Phase:  Phase 2

Learn More

Sites actively recruiting:


Los Angeles, California

Contact: Manaf Al-Sudaney


Jacksonville, Florida

Contact: Richard Smith

Contact: Sharon Smith

Miami, Florida (multiple sites)

Contact: Maida Ramallo

Contact: Yudit Cabanes

Contact: Luis E Sanchez

Palmetto Bay, Florida

Contact: Omar Orama


Baltimore, Maryland

Contact: Charalett Diggs
410-706-2122, ext 2042


Indiana – Pittsburgh, Pennsylvania

Contact: Tara McClellean


Mayo site

Contact: Lisa Bungum


Nashville, Tennessee

Contact: Sheen Wilson


Salt Lake City, Utah

Contact: Tiffany Herndon


Sites on hold:


Kansas City, Missouri

Contact: Serine Alfaress


Tampa, Florida

Contact: Cassie Miller

New York

Laurelton, New York

Contact: Ahmed Uddin