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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.

Intervention:

Drug:  Lixivaptan

Participant Information

Inclusion Criteria:

  • Male or female, between 18 and 60 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 60 years

Stage:  Recruiting

Status:  Active

Phase:  Phase 2

Learn More https://clinicaltrials.gov/ct2/show/study/NCT03487913

 

Sites actively recruiting:


California

Los Angeles, California

Contact: Manaf Al-Sudaney
323-725-0051
msudaney@amrionline.net


Florida

Jacksonville, Florida

Contact: Richard Smith
904-730-0101
rsmith@encoredocs.com

Contact: Sharon Smith
904-730-0166
ssmith@encoredocs.com

Miami, Florida (multiple sites)

Contact: Maida Ramallo
305-667-1080
Maida.crc@gmail.com

Contact: Yudit Cabanes
786-615-2861
Yc.mediclear@gmail.com

Contact: Luis E Sanchez
305-222-0155
lsanchez@healthandliferesearch.com

Palmetto Bay, Florida

Contact: Omar Orama
786-675-9452
omarorama.imrc@gmail.com

Tampa, Florida

Contact: Cassie Miller
813-873-1016
CassieMiller@genesisclinicaltrials.com


Missouri

Kansas City, Missouri

Contact: Serine Alfaress
816-756-1222
serine@crckcmo.com


New York

Laurelton, New York

Contact: Ahmed Uddin
718-276-1264
auddin@scottresearch.org


Utah

Salt Lake City, Utah

Contact: Tiffany Herndon
801-747-9186
ukrinephrology@gmail.com


Future sites not yet recruiting, check back for more information

Kansas

Kansas City, Kansas

Maryland

Baltimore, Maryland

Minnesota

Rochester, Minnesota

Pennsylvania

Indiana – Pittsburgh, Pennsylvania

Tennessee

Nashville, Tennessee