We are conducting the ELiSA Study (Evaluation of Lixivaptan In Subjects with ADPKD), a Phase 2 clinical trial that will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple doses of lixivaptan in patients with ADPKD with relatively preserved kidney function (chronic kidney disease stages CKD1 and CKD2) and moderately impaired renal function (CKD3).
This study will look at how well two different doses of the study drug, 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.
You may be able to take part in the ELiSA Study if you:
- Have been diagnosed with ADPKD by the modified Ravine criteria
- Are 18 to 65 years of age
- Have chronic kidney disease (CKD) in stages 1, 2, or 3
- Have an estimated glomerular filtration rate (eGFR) ≥ 30mL/min/1.73m2
- Are considered by the Study Investigator to be in good health relative to underlying CKD status and clinically stable with respect to underlying CKD
You will not be able to participate in the study if you:
- 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 Study Investigator, could either interfere with the study drug or pose an unacceptable risk to you as the subject
The study is currently enrolling and is expected to include up to 35 patients at approximately 15 sites in California, Florida, Kansas, Maryland, Minnesota, Missouri, New York, Pennsylvania, Tennessee, and Utah.
For more information about the ELiSA study, including contact information for sites that are actively recruiting, please visit the study record at the Clinicaltrials.gov website at this link.