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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 : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Palladio Biosciences

Tracking Information
First Submitted Date  ICMJE March 16, 2018
First Posted Date  ICMJE April 4, 2018
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE September 14, 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03487913 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autosomal Dominant Polycystic Kidney Disease
Intervention  ICMJE Drug: Lixivaptan
Oral vasopressin V2 receptor antagonist
Other Name: VPA-985
Study Arms  ICMJE
  • Experimental: High dose
    Oral lixivaptan
    Intervention: Drug: Lixivaptan
  • Experimental: Low dose
    Oral lixivaptan
    Intervention: Drug: Lixivaptan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2018)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ELiSA Study Coordinator (833) 753-5494 ELiSA_Study_Support@palladiobio.com
Contact: ELiSA Study Coordinator (833) PKD-LIXI
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03487913
Other Study ID Numbers  ICMJE PA-102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Palladio Biosciences
Study Sponsor  ICMJE Palladio Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Palladio Biosciences
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP