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

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ClinicalTrials.gov Identifier: NCT03487913
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Palladio Biosciences

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.

Condition or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney Disease Drug: Lixivaptan Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: High dose
Oral lixivaptan
Drug: Lixivaptan
Oral vasopressin V2 receptor antagonist
Other Name: VPA-985

Experimental: Low dose
Oral lixivaptan
Drug: Lixivaptan
Oral vasopressin V2 receptor antagonist
Other Name: VPA-985




Primary Outcome Measures :
  1. Number of study participants with treatment-emerging adverse events [ Time Frame: 35 days ]
    The number of study participants who experience treatment-emerging adverse events during the study will be measured.


Secondary Outcome Measures :
  1. Evaluation of the maximum observed plasma concentration of Lixivaptan in ADPKD patients [ Time Frame: 10 days ]
    The pharmacokinetic parameter Cmax will be used to measure the highest concentration of Lixivaptan in plasma after multiple doses of drug

  2. Evaluation of the area under the concentration-time curve from time 0 until the last quantifiable concentration of Lixivaptan in ADPKD patients [ Time Frame: 10 days ]
    The pharmacokinetic parameter AUC0-last for Lixivaptan, calculated using the linear trapezoidal rule for increasing values and the log trapezoidal rule for decreasing values, will be measured and summarized by dose

  3. Mean change from baseline in trough urine osmolality after 7 days of treatment with Lixivaptan in ADPKD patients [ Time Frame: 7 days ]
    Spot urine osmolality at trough (mOsm/kg) will be determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline) and Day 7.

  4. Mean change from baseline in serum creatinine after 7 days of treatment with Lixivaptan in ADPKD patients [ Time Frame: 7 days ]
    Serum creatinine (mg/dL) will be determined from plasma samples collected immediately prior to morning dosing for Day 1 (Baseline) and Day 7.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, between 18 and 60 years of age
  • 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, mesylate, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487913


Contacts
Contact: ELiSA Study Coordinator (833) 753-5494 ELiSA_Study_Support@palladiobio.com

Locations
United States, California
Palladio Biosciences Clinical Site Recruiting
Los Angeles, California, United States, 90022
United States, Florida
Palladio Biosciences Clinical Site Recruiting
Jacksonville, Florida, United States, 32216
Contact: Kevin Adams    904-730-0101    kadams@encoredocs.com   
United States, Missouri
Palladio Biosciences Clinical Site Recruiting
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Palladio Biosciences

Responsible Party: Palladio Biosciences
ClinicalTrials.gov Identifier: NCT03487913     History of Changes
Other Study ID Numbers: PA-102
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn