Euvolemic HyponatremiaPhase 3NCT00876798
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia
A Phase 3 study testing Lixivaptan in people with Euvolemic Hyponatremia, run by CardioKine Inc. at 90 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan capsules in subjects with Euvolemic Hyponatremia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Euvolemic Hyponatremia
- 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
- 206 participants
- Where
- 90 sitesin 8 countries
- Study dates
- Jun 2009to Nov 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 (Na+ < 135 mEq/L).
- Willing to be observed in a monitored setting for approximately the first 8 hours following treatment initiation (first dose).
- In the Investigator's judgement the patient has adequate visual and auditory acuity to allow participation in the trial.
Who cannot join
- Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed.
- Overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
- Acute or transient hyponatremia (e.g., associated with head trauma, postoperative state, or use of radiotherapy and/or chemotherapy).
- Hyponatremia in hypovolemic states (e.g., due to fluid loss through vomiting, diarrhea, burns, etc.). Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion.
- Hyponatremia in hypervolemic states (e.g., congestive heart failure). Hypervolemia is defined as a presence of increased total body water with signs of edema.
- Pseudohyponatremia (i.e., hyponatremia resulting from a laboratory artifact).
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- Hypertonic hyponatremia (e.g., hyponatremia in the setting of hyperglycemia).
- Hyponatremia as a result of any medication that can safely be withdrawn.
- Hyponatremia due to hypothyroidism or adrenal insufficiency.
- Current diagnosis of psychogenic polydipsia.
- Receiving within 7 days of enrollment other medication for treatment of hyponatremia, specifically: demeclocycline, lithium carbonate, urea, or any vasopressin antagonist.
- Supine systolic arterial blood pressure of ≤ 90 millimeters of mercury (mmHg).
- Serum creatinine > 3.0 mg/dL (> 265.2 mol/L).
- Hypokalemia based on clinical sign/symptoms or lab findings (e.g., serum potassium < 3.5 mEq/L).
- Uncontrolled diabetes mellitus as defined by the Investigators (e.g., hemoglobin - glycosylated [HbA1c] > 9%).
- ST-segment elevation myocardial infarction (STEMI) within 30 days or active myocardial ischemia at the time of enrollment.
- History of cerebral vascular accident (CVA) within 30 days prior to screening.
- Severe malnutrition in the Investigator's judgment (e.g., body mass index [BMI] < 17).
- Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis.
- Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive).
- History of chronic drug/medication abuse within the past 6 months or current alcohol abuse.
- 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 within 30 days prior to baseline visit.
- Unable to take oral medications.
- Significant neurological disorders (e.g., permanent neurological deficits, probable Alzheimer's disease, normal pressure hydrocephalus, Parkinsonian dementia complex, multi-infarct dementia, mixed dementia, or Huntington's disease).
- Conditions limiting access to water or an inability to respond to thirst (e.g., hydrophobia, or non-communicative).
Trial locations and contacts
90 sites in 8 countries.
90 sites in 8 countries
United States66 sites
Executive Health and Research Associates
Atlanta, Georgia, 30342
Senior Care of Colorado, PC
Aurora, Colorado, 80014
Senior Adults Specialty Research
Austin, Texas, 78757
Levindale Hebrew Geriatric Center and Hospital
Baltimore, Maryland, 21215
LifeBridge Health, Inc./ Courtland Gardens Nursing & Rehabilitation Center
Baltimore, Maryland, 21215
Stephen R. Smith
Baltimore, Maryland, 21234
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
Birmingham Nursing and Rehabilitation East
Birmingham, Alabama, 35205
Naples Institute for Clinical Research
Bonita Springs, Florida, 34134
Buffalo VA Medical Center
Buffalo, New York, 14215
Erie County Medical Center/SUNY at Buffalo affiliate
Buffalo, New York, 14215
Mercury Street Medical Group
Butte, Montana, 59701
AV Institute, Inc.
Carson, California, 90746
Valley Medical Research
Centerville, Ohio, 45459
Hilltop Physicians Inc
Cincinnati, Ohio, 45224
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Translational Neuroscience, LLC/Drexel University College of Medicine
Conshohocken, Pennsylvania, 19428
Rockdale Medicall Research Associates
Conyers, Georgia, 30094
Providence Health Partners - Center for Clinical Research
Dayton, Ohio, 45439
Clinical Research and Consulting Center
Fairfax, Virginia, 22030
Genesis Clinical Research & Consulting, LLC
Fall River, Massachusetts, 02720
Lillestol Research LLC
Fargo, North Dakota, 58103
Royal Care Nursing Home
Fountain Valley, California, 92708
Internal Medical Associates of Grand Island, PC
Grand Island, Nebraska, 68803
Sarah S. Olelewe, MD, Inc.
Hawthorne, California, 90250
Memorial Hermann - Memorial City Research Center
Houston, Texas, 77024
Ilumina CLinical Associates
Indiana, Pennsylvania, 15701
Jacksonville Center for CLinical Research
Jacksonville, Florida, 32216
Parkview Rehabilitation and Nursing
Little Rock, Arkansas, 72204
Torrance Clinical Research
Lomita, California, 90717
South Texas Institutes of Health
McAllen, Texas, 78501
Your Diabetes Endocrine Nutrition Group, Inc.
Mentor, Ohio, 44060
Miami Jewish Home and Hospital for the Aged
Miami, Florida, 33137
Galiz Research
Miami, Florida, 33145
Nephrology Associates of South Miami
Miami, Florida, 33173
Galiz Research
Miami Springs, Florida, 33166
Healthscan Research, LLC
Montgomery, Alabama, 36109
Natchitoches Internal Medicine
Natchitoches, Louisiana, 71457
Parker Jewish Institute for Health Care and Rehabilitation
New Hyde Park, New York, 11040
John J. Hainkel Jr Home and Rehabilitation Center
New Orleans, Louisiana, 70118
Piedmont Clinical Trials
North Miami, Florida, 33161
Scientific Clinical Research, Inc.
North Miami, Florida, 33161
COR Clinical Research LLC
Oklahoma City, Oklahoma, 73103
ASpen CLinical Research
Orem, Utah, 84058
Universal Clinical Research & Technology, Inc.
Orlando, Florida, 32833
University Clinical Research & Technology, Inc.
Orlando, Florida, 32833
Research Integrity, LLC
Owensboro, Kentucky, 42303
Four Rivers Clinical Research
Paducah, Kentucky, 42003
PsyPharma Clinical Research, Inc.
Phoenix, Arizona, 85050
PsyPharma Clinical Research
Phoenix, Arizona, 85050
Coastal Nephrology Associates Reserach Center
Port Charlotte, Florida, 33952
McGuire VA Medical Center
Richmond, Virginia, 23249
Rochester General Hospital
Rochester, New York, 14621
InVisions Consultants, LLC
San Antonio, Texas, 78229
RTR Medical Group
Savannah, Georgia, 31419
Searcy Medical Center
Searcy, Arkansas, 72143
Western New England Renal & Transplant Assciates, PC
Springfield, Massachusetts, 01107
Medical Research Development Associates, LLC
Springfield Gardens, New York, 11413
Millenium Psychiatric Associates
St Louis, Missouri, 63044
SLU Care Doctors Office Building
St Louis, Missouri, 63110
Carolina Diabetes and Kidney Center
Sumter, South Carolina, 29150
Olive View - UCLA Medical Center
Sylmar, California, 91342
Universal Research Group
Tacoma, Washington, 98405
Toulon Health Care Center
Toulon, Illinois, 61483
Southern Arizona VA Health Care System (SAVAHCS)
Tucson, Arizona, 85723
Three Rivers Health and Rehabilitation
Windsor, North Carolina, 27983
India10 sites
Smt G.R. Doshi & Smt K.M. Mehta Institute of Kidney Diseases & Reseacrh Cnetre (IKDRC) & Dr. H.L. Trivedi Institute of Transplantation Services (ITS)
Asarwa, Ahmedabad, 380 016
M. S. Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054
Department of Neurology St. John's Medical College & Hospital
Bangalore, 560034
Kamineni Hospitals
Hyderabad, Andhra Pradesh, 500 068
Justice K. S. Hedge Charitable Hospital
Karnataka, Mangalore, 575018
Bhatia Hospital, G-1 Ward
Mumbia, Maharashtra, 400 007
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, Maharashtra, 411 001
Dayanand Medical College and Hospital
Tagorenagar, Ludhiana, 141 001
Kovai Medical Centre & Hospital
Tamil Nadu, Coimbatore, 54013
Apollo Hospitals
Tanil Nadu, Chennai, 600 006
Israel4 sites
Diabetic and Endocrine Unit, Hillel Yaffe Medical Center
Hadera, 38100
Hadassah Medical Organization, Hadassah University Hospital, Ein Karem
Kiryat Hadassah, Jerusalem, 91120
The Endocrine Institute, Rabin Medical Center, Beilinson Hospital
Petah Tikvah, 49100
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Italy3 sites
Presidio ospedaliero zona aretina, Ospedale San Donato di Arezzo
Pietro Nenni, Arezzo, 52100
Medicina II, Arcispedale Santa Maria Nuova
Reggio Emilia, 42100
SOD Clinica di Endocrinologia a Malatte del Metabolismo
Torette Di Ancona, Torette Di Ancona, 60126
Czechia2 sites
Klinika nefrologie VFN a 1.LF UK
Nemocnice 2, Prague, 12808
Fakultni nemocnice Ostrava Neurologicke oddeleni
Ostrava, Poruba, 70852
Mexico2 sites
Instituto Biomedico de Investigacion A.C.
Aguascalientes, 20127
Hospital General "Dr. Santiago Ramon Y Cajal" I.S.S.S.T.E.
Durango, Mexico, 34070
Peru2 sites
Hospital Nacional Guillermo Almenara Irigoyen-EsSalud.
Lima, Peru, Lima 13
Hospital Nacional Arzobispo Loayza
Lima, Peru, Lima 1
About this study
The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan capsules in subjects with Euvolemic Hyponatremia.
Read the detailed description
Phase I and 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, LCWA, and SIADH. Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH) and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan demonstrated correction in serum sodium concentration together with marked aquaresis in subjects with hyponatremia.
- Conditions
- Euvolemic Hyponatremia
- Being tested
- Lixivaptan, Placebo
- Keywords
- Euvolemic Hyponatremia, SIADH, Serum Sodium
- Medical subject headings
- Inappropriate ADH Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LixivaptanDrug
Capsules, 25mg lixivaptan or matching placebo once daily. Study medication can be titrated up to 50mg or 100mg once daily. Acceptable dosages are once daily administration of 25mg, 50mg, or 100mg as a single dose.
PlaceboDrug
Capsule. Subjects will be randomized (3:1) on an outpatient basis to 25 mg lixivaptan or matching placebo, once daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lixivaptan Receives: Drug: Lixivaptan |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that lixivaptan is safe and effective in achieving and maintaining increased serum sodium concentration in subjects with SIADH and other conditions of euvolemic hyponatremia.
Measured: 6 months
Secondary outcomes (1)
If lixivaptan demonstrates improvement in serum sodium, % of subjects achieving normalized serum sodium, % of subjects requiring fluid restriction, prevention of worsening hyponatremia, and the change from baseline to complete TMT-B.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Euvolemic HyponatremiaStudies 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
- 206 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
- NCT00876798
- Sponsor's protocol ID
- CK-LX3430
- Status last verified
- Nov 2010
- First submitted
- 6 Apr 2009
- 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
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia
- ClinicalTrials.gov ID
- NCT00876798
- Acronym / sponsor ID
- CK-LX3430
- Conditions
- Euvolemic Hyponatremia
- Keywords
- Euvolemic Hyponatremia, SIADH, Serum Sodium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- CardioKine Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cardiokine Biopharma, LLC, Biogen
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (actual)
- First posted
- 7 Apr 2009 (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 purpose of this study is to evaluate the safety and tolerability of oral lixivaptan capsules in subjects with Euvolemic Hyponatremia.
Detailed description
Phase I and 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, LCWA, and SIADH. Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH) and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan demonstrated correction in serum sodium concentration together with marked aquaresis in subjects with hyponatremia.
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 |
|---|---|---|
| 1 | Experimental | Drug: LixivaptanLixivaptan |
| 2 | 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 (5 listed)
- Written informed consent.
- Men or women aged 18 or older.
- Diagnosis of euvolemic hyponatremia (Na+ < 135 mEq/L).
- Willing to be observed in a monitored setting for approximately the first 8 hours following treatment initiation (first dose).
- In the Investigator's judgement the patient has adequate visual and auditory acuity to allow participation in the trial.
Key exclusion criteria (29 listed)
- Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed.
- Overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
- Acute or transient hyponatremia (e.g., associated with head trauma, postoperative state, or use of radiotherapy and/or chemotherapy).
- Hyponatremia in hypovolemic states (e.g., due to fluid loss through vomiting, diarrhea, burns, etc.). Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion.
- Hyponatremia in hypervolemic states (e.g., congestive heart failure). Hypervolemia is defined as a presence of increased total body water with signs of edema.
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 |
|---|---|---|
| LixivaptanCapsules, 25mg lixivaptan or matching placebo once daily. Study medication can be titrated up to 50mg or 100mg once daily. Acceptable dosages are once daily administration of 25mg, 50mg, or 100mg as a single dose. | Drug | 1 |
| PlaceboCapsule. Subjects will be randomized (3:1) on an outpatient basis to 25 mg lixivaptan or matching placebo, once daily. | Drug | 2 |
Primary outcome
To demonstrate that lixivaptan is safe and effective in achieving and maintaining increased serum sodium concentration in subjects with SIADH and other conditions of euvolemic hyponatremia.
Time frame: 6 months
1 secondary outcome
If lixivaptan demonstrates improvement in serum sodium, % of subjects achieving normalized serum sodium, % of subjects requiring fluid restriction, prevention of worsening hyponatremia, and the change from baseline to complete TMT-B.
Time frame: 6 months
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.
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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.
90 sites in 8 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 Euvolemic Hyponatremia, run by CardioKine Inc. at 90 sites in 8 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 5 inclusion and 29 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 90 sites in United States, India, Israel, Italy, Czechia and 3 more countries. 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?
To demonstrate that lixivaptan is safe and effective in achieving and maintaining increased serum sodium concentration in subjects with SIADH and other conditions of euvolemic hyponatremia. (time frame: 6 months). 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.