The ELiSA Study – Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

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Brief Title

The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

Official Title

A Phase 2, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

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 Dominant Polycystic Kidney Disease subjects with chronic kidney disease in
      stages CKD1, CKD2 or CKD3.
    

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 polycystic kidney disease (ADPKD).

      The primary objectives of this study in subjects with ADPKD are:

        -  To characterize the safety and tolerability of lixivaptan following multiple doses in
           ADPKD subjects with relatively preserved kidney function (chronic kidney disease CKD1
           and CKD2) and moderately impaired renal function (CKD3).

      The secondary objectives of this study are:

        -  To characterize the PK profile of lixivaptan and its major metabolites following
           multiple doses of lixivaptan in ADPKD subjects with relatively preserved kidney function
           (CKD1 and CKD2) and moderately impaired renal function (CKD3).

        -  To characterize the pharmacodynamic effect of lixivaptan on urine output, urine
           osmolality, total kidney volume, serum vasopressin, and serum creatinine following
           multiple doses of lixivaptan in ADPKD subjects with relatively preserved kidney function
           (CKD1 and CKD2) and moderately impaired renal function (CKD3).
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of study participants with treatment-emerging adverse events

Secondary Outcome

 Evaluation of the maximum observed plasma concentration of Lixivaptan in ADPKD patients

Condition

Autosomal Dominant Polycystic Kidney Disease

Intervention

Lixivaptan

Study Arms / Comparison Groups

 High dose
Description:  Oral lixivaptan

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

31

Start Date

September 14, 2018

Completion Date

February 11, 2020

Primary Completion Date

December 2, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  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 Criteria:

          -  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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Vicente E Torres, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03487913

Organization ID

PA-102


Responsible Party

Sponsor

Study Sponsor

Palladio Biosciences


Study Sponsor

Vicente E Torres, MD, PhD, Principal Investigator, Mayo Clinic


Verification Date

November 2020