Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia

June 20, 2011 updated by: CardioKine Inc.

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia

The present study is designed to confirm and extend the observation from previous studies that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with SIADH.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase I Phase II clinical trials have demonstrated that lixivaptan may play an important role in treating hyponatremia and the signs and symptoms of water retention associated with HF, liver cirrhosis with ascites (LCWA) and syndrome of inappropriate antidiuretic hormone (SIADH). Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH)and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan resulted in correction in hyponatremia together with a marked aquaresis in subject with volume overload. The present study is designed to confirm and extend the observation from previous studies that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with SIDH.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Gasthulsberg
      • Tubize, Belgium, 1480
        • Centre Hospitalier de Tubize
  • Canada
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Research Site
      • Montreal, Quebec, Canada, H4J 1C5
        • Research Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Research Site 1
  • Germany
      • Berlin, Germany, 12200
        • Research Site
      • Berlin, Germany, 13353
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Giessen, Germany, 35392
        • Research Site
      • Hannover, Germany, 30167
        • Research Site
      • Heidelberg, Germany, 69120
        • Research Site
      • Konstanz, Germany, 78464
        • Research Site
      • Magdeburg, Germany, 39120
        • Research Site
      • Munchen, Germany, 80336
        • Research Site
      • Wurzburg, Germany, 97080
        • Research Site
  • India
      • New Delhi, India, 110 065
        • Vidya Sagar Institute of Mental Health and Neurosciences
    • Kerala
      • Calicut, Kerala, India, 673004
        • Baby Memorial Hospital
    • Maharashtra
      • Pune, Maharashtra, India, 411 030
        • Poona hospital and research centre
    • New Delhi
      • Old Rajinder Nagar, New Delhi, India, 110060
        • Sir Ganga Ram Hospital
    • Pune
      • Erandawane, Pune, India, 411 004
        • Deenanath Mengeshkar Hospital & Research Centre
    • Rajastan
      • Jaipur, Rajastan, India, 302017
        • Fortis Escorts Hospital
  • Poland
      • Bydgoszcz, Poland, 85-094
        • Research Site
      • Ciechanow, Poland, 06400
        • Research Site 1
      • Katowice, Poland, 40-027
        • Research Site
      • Lodz, Poland, 90-153
        • Research Site 1
      • Lublin, Poland, 20-954
        • Research Site
      • Podlaski, Poland, 08-300
        • Research Site 1
      • Warszawa, Poland, 02-097
        • Research Site
      • Warszawa, Poland
        • Research Site 1
      • Warszawa, Poland, 02-507
        • Research Site 1
      • Warszawa, Poland, 02-097
        • Research Site 1
      • Zamosc, Poland, 22-400
        • Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
    • Lodz
      • Wilgury, Lodz, Poland, 90-302
        • Niepubliczny Zaklad Opieki Zdrowotney
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • Research Site 1
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • PsyPharma Global
    • California
      • Los Angeles, California, United States, 90033
        • Research Site
      • Los Angeles, California, United States, 90073
        • Research Site 1
      • Roseville, California, United States, 95661
        • Research Site 1
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The George Washington University Medical Faculty Associates
    • Florida
      • North Miami, Florida, United States, 33161
        • Healthcare Clinical Data, Inc
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Research Site
      • Savannah, Georgia, United States, 31419
        • RTR Medical Group
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Research Site 1
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Four Rivers Clinical Research, Inc.
    • Louisiana
      • New Orleans, Louisiana, United States, 70114
        • Louisiana Research Associates, Inc.
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • Research Site
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02135
        • Research Site
      • Boston, Massachusetts, United States, 02212
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Research Site 1
    • New York
      • Albany, New York, United States, 12208
        • Research Site 1
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center
      • New York, New York, United States, 10016
        • Research Site
    • North Carolina
      • Windsor, North Carolina, United States, 27983
        • Three Rivers Health and Rehabilitation
    • Ohio
      • Middletown, Ohio, United States, 45005
        • Atrium Medical Center
      • Toledo, Ohio, United States, 43609
        • Kettlie Joseph Daniels MD, Inc
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Research Site 1
      • Doylestown, Pennsylvania, United States, 18901
        • Research Site 1
      • Norristown, Pennsylvania, United States, 19401
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site 1
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States, 29209
        • Research Site 1
    • Texas
      • Georgetown, Texas, United States, 78626
        • SunStar Geriatrics Healthcare
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
    • Utah
      • Orem, Utah, United States, 84058
        • Aspen Clinical Research
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • The Glennan Center for Geriatrics and Gerontology
    • Washington
      • Tacoma, Washington, United States, 98405
        • Internal Medicine Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Men or women aged 18 or older
  • Diagnosis of euvolemic hyponatremia (120 ≤ Na+<130 mEq/L)
  • Hospitalized or willing to be admitted to a monitored setting for approximately the first 48 hours of treatment

Exclusion Criteria:

  • Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed
  • Symptomatic hyponatremia (e.g., lethargy, coma, seizures, changes in mental status attributable to hyponatremia)
  • Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state)
  • Hyponatremia in hypovolemic states. Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion
  • Hyponatremia as a result of any medication that can safely be withdrawn
  • Hyponatremia due to hypothyroidism or adrenal insufficiency
  • Diagnosis of psychogenic polydipsia
  • Receiving within 7 days of enrollment, other medication for treatment of hyponatremia specifically: demeclocycline, lithium carbonate, urea, or conivaptan
  • Use of radiotherapy and chemotherapy within 2 wks of randomization
  • Likely to require, or to receive IV saline for correction of symptomatic or asymptomatic severe hyponatremia during the course of the study
  • Supine systolic arterial blood pressure of ≤ 90 mmHg
  • Serum creatinine >3.0 mg/dL
  • History of uncontrolled type 2 diabetes mellitus
  • Severe pulmonary artery hypertension: patients whose condition is expected to deteriorate with sudden shifts in fluid volumes and cardiac filling pressures
  • Established diagnosis of New York Heart Association (NYHA) class III or IV heart failure
  • History of myocardial infarction, unstable angina or evidence of active ischemia within 30 days prior to screening
  • History of cerebral vascular accident (CVA) within 60 days prior to screening
  • Established diagnosis of nephrotic syndrome
  • Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis
  • Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive)
  • History of alcohol abuse or illicit drug use within the past 6 months
  • Terminally ill or moribund condition with little chance of short-term survival
  • Receiving vasopressin or its analogs for treatment of any condition
  • Known allergy to any vasopressin antagonist
  • Previous participation in a lixivaptan study
  • Recipient of any investigational treatment (drug or device) within 30 days prior to baseline visit
  • Unable to take oral medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo
Drug: placebo
oral capsule
Experimental: Active Comparator
lixivaptan
Drug: lixivaptan
oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average daily area under the curve (AUC) of change from baseline in serum sodium concentrations up to 72 hrs in lixivaptan treated subjects compared to placebo
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in serum sodium on Day 30
Time Frame: 60 days
60 days
Percentage of subjects achieving normalized serum sodium (Na+ ≥ 135 mEq/L)
Time Frame: 60 days
60 days
Time to first normalization of serum sodium (Na+≥135 mEq/L)
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioKine Inc.

Collaborators

Biogen
Cardiokine Biopharma, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

June 28, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CK-LX3405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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