Hyponatremia With Normal Extracellular Fluid VolumeNCT01056848
International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430
An observational study of Hyponatremia With Normal Extracellular Fluid Volume and Hyponatremia With Excess Extracellular Fluid Volume, run by CardioKine Inc. at 6 sites in United States.
Trial summary
To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic hyponatremia 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, Hyponatremia With Excess Extracellular Fluid Volume
- How many people
- 135 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2010to Jun 2011
- Phase
- Observational
- 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
Study population: Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia (CK-LX3401, CK-LX3405, or CK-LX3430)
Who may be able to join
- Men and women 18 years of age or older
- Ability to provide informed consent or assent
- Prior participation in a lixivaptan hyponatremia trial with evidence of continued need or desire for therapy
Who cannot join
- A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient
- Hyponatremia which is acute, reversible, artificial or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy
- Hyponatremia due to reversible medical condition or therapy
- Conditions associated with an independent imminent risk of morbidity and mortality
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Innovative Research of West Florida
Clearewater, Florida, 33756
Millenium Psychiatric Associates, LLC
Creve Cour, Missouri, 63141
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003
Internal Medical Associates of Grand Island, PC
Grand Island, Nebraska, 68803
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Torrance Clinical Research
Lomita, California, 90717
About this study
To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic 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 patients with hyponatremia.
- Conditions
- Hyponatremia With Normal Extracellular Fluid Volume, Hyponatremia With Excess Extracellular Fluid Volume
- Keywords
- Euvolemic Hyponatremia, Hypervolemic 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.
| Study group | Role | What they receive |
|---|---|---|
| CK-LX3401 | Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia. | |
| CK-LX3405 | Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia | |
| CK-LX3430 | Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of long-term lixivaptan use in patients who were previously enrolled in one of the 3 Phase III trials.
Measured: 28 weeks
Secondary outcomes (1)
To demonstrate that after open-label lixivaptan treatment: improvements in the time to complete the TMT-B will be maintained compared to baseline, and improvements in the Medical Outcomes Survey will be maintained compared to baseline.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 135 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
- NCT01056848
- Sponsor's protocol ID
- CK-LX3431
- Status last verified
- Jun 2011
- First submitted
- 22 Jan 2010
- Last updated
- 21 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430
- ClinicalTrials.gov ID
- NCT01056848
- Acronym / sponsor ID
- CK-LX3431
- Conditions
- Hyponatremia With Normal Extracellular Fluid Volume, Hyponatremia With Excess Extracellular Fluid Volume
- Keywords
- Euvolemic Hyponatremia, Hypervolemic Hyponatremia, SIADH, Serum Sodium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- CardioKine Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cardiokine Biopharma, LLC, Biogen
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- First posted
- 26 Jan 2010 (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.
To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic 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 patients with hyponatremia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CK-LX3401 | – | –Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia. |
| CK-LX3405 | – | –Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia |
| CK-LX3430 | – | –Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia (CK-LX3401, CK-LX3405, or CK-LX3430)
Key inclusion criteria (3 listed)
- Men and women 18 years of age or older
- Ability to provide informed consent or assent
- Prior participation in a lixivaptan hyponatremia trial with evidence of continued need or desire for therapy
Key exclusion criteria (4 listed)
- A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient
- Hyponatremia which is acute, reversible, artificial or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy
- Hyponatremia due to reversible medical condition or therapy
- Conditions associated with an independent imminent risk of morbidity and mortality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the safety of long-term lixivaptan use in patients who were previously enrolled in one of the 3 Phase III trials.
Time frame: 28 weeks
1 secondary outcome
To demonstrate that after open-label lixivaptan treatment: improvements in the time to complete the TMT-B will be maintained compared to baseline, and improvements in the Medical Outcomes Survey will be maintained compared to baseline.
Time frame: 28 weeks
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 21 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia With Normal Extracellular Fluid Volume and Hyponatremia With Excess Extracellular Fluid Volume, run by CardioKine Inc. at 6 sites in United States.
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 3 inclusion and 4 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 21 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 6 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 assess the safety of long-term lixivaptan use in patients who were previously enrolled in one of the 3 Phase III trials. (time frame: 28 weeks). 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 21 Jun 2011.