Hyponatremia With Normal Extracellular Fluid VolumePhase 3NCT00660959
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia
A Phase 3 study testing lixivaptan in people with Hyponatremia With Normal Extracellular Fluid Volume, run by CardioKine Inc. at 71 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia With Normal Extracellular Fluid Volume
- What is being tested?
- lixivaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 71 sitesin 6 countries
- Study dates
- Apr 2008to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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- Hyponatremia as a result of any medication that can safely be withdrawn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
Show all 27Show fewer
- 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
Trial locations and contacts
71 sites in 6 countries.
71 sites in 6 countries
United States38 sites
Research Site 1
Albany, New York, 12208
Research Site
Augusta, Georgia, 30912
Research Site
Aurora, Colorado, 80045
Research Site
Belmont, Massachusetts, 02478
Research Site
Boston, Massachusetts, 02135
Research Site
Boston, Massachusetts, 02212
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Erie County Medical Center
Buffalo, New York, 14215
Research Site 1
Camp Hill, Pennsylvania, 17011
Research Site
Chicago, Illinois, 60612
Research Site 1
Columbia, South Carolina, 29209
Research Site 1
Doylestown, Pennsylvania, 18901
SunStar Geriatrics Healthcare
Georgetown, Texas, 78626
Clinical Trial Network
Houston, Texas, 77074
Research Site 1
Iowa City, Iowa, 52242
Research Site
Kansas City, Missouri, 64128
Research Site 1
Las Vegas, Nevada, 89106
Research Site
Los Angeles, California, 90033
Research Site 1
Los Angeles, California, 90073
Atrium Medical Center
Middletown, Ohio, 45005
Research Site 1
Mobile, Alabama, 36617
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114
Research Site
New York, New York, 10016
The Glennan Center for Geriatrics and Gerontology
Norfolk, Virginia, 23507
Research Site
Norristown, Pennsylvania, 19401
Healthcare Clinical Data, Inc
North Miami, Florida, 33161
Aspen Clinical Research
Orem, Utah, 84058
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, 42003
Research Site 1
Philadelphia, Pennsylvania, 19104
PsyPharma Global
Phoenix, Arizona, 85050
Research Site
Providence, Rhode Island, 02903
Research Site 1
Roseville, California, 95661
RTR Medical Group
Savannah, Georgia, 31419
Internal Medicine Northwest
Tacoma, Washington, 98405
Kettlie Joseph Daniels MD, Inc
Toledo, Ohio, 43609
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Cleveland Clinic Florida
Weston, Florida, 33331
Three Rivers Health and Rehabilitation
Windsor, North Carolina, 27983
Poland12 sites
Research Site
Bydgoszcz, 85-094
Research Site 1
Ciechanów, 06400
Research Site
Katowice, 40-027
Research Site 1
Lodz, 90-153
Research Site
Lublin, 20-954
Research Site 1
Podlaski, Poland, 08-300
Research Site 1
Warsaw, Poland
Research Site 1
Warsaw, 02-097
Research Site
Warsaw, 02-097
Research Site 1
Warsaw, 02-507
Niepubliczny Zaklad Opieki Zdrowotney
Wilgury, Łódź Voivodeship, 90-302
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
Zamość, Zamosc, 22-400
Germany10 sites
Research Site
Berlin, 12200
Research Site
Berlin, 13353
Research Site
Dresden, Germany, 01307
Research Site
Giessen, 35392
Research Site
Hanover, Hannover, 30167
Research Site
Heidelberg, 69120
Research SIte
Konstanz, 78464
Research Site
Magdeburg, Magdeburg, 39120
Research Site
München, 80336
Research Site
Würzburg, 97080
India6 sites
Baby Memorial Hospital
Calicut, Kerala, 673004
Deenanath Mengeshkar Hospital & Research Centre
Erandawane, Pune, 411 004
Fortis Escorts Hospital
Jaipur, Rajasthan, 302017
Vidya Sagar Institute of Mental Health and Neurosciences
New Delhi, New Delhi, 110 065
Sir Ganga Ram Hospital
Old Rajinder Nagar, New Delhi, 110060
Poona Hospital and Research Centre
Pune, Maharashtra, 411 030
Canada3 sites
Research SIte
Greenfield Park, Quebec, J4V 2H1
Research Site 1
Montreal, Quebec, H1T 2M4
Research Site
Montreal, Quebec, H4J 1C5
Belgium2 sites
UZ Gasthulsberg
Leuven, 3000
Centre Hospitalier de Tubize
Tubize, 1480
About this study
Official title: 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.
Read the 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.
- Being tested
- lixivaptan, placebo
- Keywords
- Euvolemic, Hyponatremia, Serum Sodium, Fluid Overload, Vasopressin Antagonist
- Medical subject headings
- Hyponatremia, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lixivaptanDrug
oral capsule
placeboDrug
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Experimental | lixivaptan Receives: Drug: lixivaptan |
| Placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 days
Secondary outcomes (3)
Change from baseline in serum sodium on Day 30
Measured: 60 days
Percentage of subjects achieving normalized serum sodium (Na+ ≥ 135 mEq/L)
Measured: 60 days
Time to first normalization of serum sodium (Na+≥135 mEq/L)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyponatremia With Normal Extracellular Fluid VolumeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioKine Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardiokine Biopharma, LLC, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660959
- Sponsor's protocol ID
- CK-LX3405
- Status last verified
- Nov 2010
- First submitted
- 15 Apr 2008
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia
- ClinicalTrials.gov ID
- NCT00660959
- Acronym / sponsor ID
- CK-LX3405
- Keywords
- Euvolemic, Hyponatremia, Serum Sodium, Fluid Overload, Vasopressin Antagonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- CardioKine Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cardiokine Biopharma, LLC, Biogen
- Study start
- Apr 2008
- Primary completion
- Jun 2010 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Experimental | Drug: lixivaptanlixivaptan |
| Placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lixivaptanoral capsule | Drug | Active Comparator |
| placebooral capsule | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
Change from baseline in serum sodium on Day 30
Time frame: 60 days
Percentage of subjects achieving normalized serum sodium (Na+ ≥ 135 mEq/L)
Time frame: 60 days
Time to first normalization of serum sodium (Na+≥135 mEq/L)
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
71 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lixivaptan in people with Hyponatremia With Normal Extracellular Fluid Volume, run by CardioKine Inc. at 71 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Poland, Germany, India, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.