Status:
COMPLETED
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Lead Sponsor:
Palladio Biosciences
Conditions:
Autosomal Dominant Polycystic Kidney Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a Phase 2, open-label, parallel-group, multiple dose study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of lixivaptan in Autosomal Dom...
Detailed Description
Therapeutic interventions aimed at counterbalancing the effect of vasopressin and/or normalizing intracellular levels of cAMP may be effective in delaying disease progression in autosomal dominant pol...
Eligibility Criteria
Inclusion
- Male or female, between 18 and 65 years of age at the time of screening
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 with eGFR calculated by the CKD EPI equation
- Diagnosed with ADPKD by modified Ravine criteria
- Considered by Investigator to be in good health relative to underlying CKD status and clinically stable with respect to underlying CKD
Exclusion
- Known sensitivity or idiosyncratic reaction to lixivaptan, its related compounds such as benzazepines (e.g., tolvaptan, conivaptan, benazepril, fenoldopam, or mirtazapine), or any compound listed as being present in the study formulation
- Women who are pregnant or breast feeding
- Subjects have taken tolvaptan, oral or intravenous antibiotics, or any investigational drug or used an investigational device within 30 days or 5 half-lives, whichever is longer, prior to first study dose
- Subject has a transplanted kidney, or absence of a kidney
- Subjects with clinically significant incontinence, overactive bladder, or urinary retention (e.g., benign prostatic hyperplasia)
- Subjects with clinically significant liver disease, or clinically significant liver function abnormalities or serology other than that expected for ADPKD with cystic liver disease at baseline
- Subjects with any clinically significant concomitant disease or condition other than 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
Key Trial Info
Start Date :
September 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03487913
Start Date
September 14 2018
End Date
February 11 2020
Last Update
December 5 2022
Active Locations (13)
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1
Palladio Biosciences Clinical Site
Los Angeles, California, United States, 90022
2
Palladio Biosciences Clinical Site
Jacksonville, Florida, United States, 32216
3
Palladio Biosciences Clinical Site
Miami, Florida, United States, 33155
4
Palladio Biosciences Clinical Site
Miami, Florida, United States, 33165