Hypervolemic HyponatremiaPhase 3NCT00876876
International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia
A Phase 3 study testing Lixivaptan in people with Hypervolemic Hyponatremia, run by CardioKine Inc..
Trial summary
To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo during the 4 week double blind treatment period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypervolemic 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
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Dec 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
- Men and Women with age greater than or equal to 18 years.
- Prior successful participation in a randomized, blinded, placebo-controlled Phase 3 lixivaptan study of hyponatremia in Heart Failure (Protocol CK-LX3401) with evidence of continued need for therapy as follows:
- Patient completed full course of treatment (e.g., either placebo or lixivaptan). Treatment assignments for Protocol CK-LX3401 will not be unblinded prior to participation in the extension study.
- Baseline serum sodium concentration < 135 mEq/L following a 30 day post treatment follow-up period in a lixivaptan hyponatremia parent trial. Repeat measures of serum sodium are allowed; the last serum sodium result within 24 hours prior to randomization will serve as the qualifying measurement.
- The patient has clinical evidence of volume overload with at least one of the following:
- Dyspnea
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- Pulmonary congestion (rales)
- Peripheral edema
- Increased jugular venous pressure and/or hepatic congestion with ascites
- Chest x-ray consistent with CHF; OR
- Plasma BNP ≥150 pg/mL or NT pro-BNP ≥ 450 pg/mL
Who cannot join
- Women who are pregnant (positive pregnancy test), breastfeeding or who will not adhere to the reproductive precautions as outlined in this protocol and in the informed consent form.
- Inability to provide informed consent.
- Acute severe hyponatremia with overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
- Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state).
- Hyponatremia in hypovolemic states. Hypovolemia is defined as the presence of clinical evidence of fluid volume depletion.
- Euvolemic Hyponatremia (e.g., SIADH, etc.). Euvolemic hyponatremia is defined as low serum sodium in the presence of normal total body sodium due to mild to moderate increases in total body water without edema.
About this study
To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo during the 4 week double blind treatment period.
- Conditions
- Hypervolemic Hyponatremia
- Being tested
- Lixivaptan
- Keywords
- hypervolemic hyponatremia, serum sodium, fluid overload, heartfailure, acute heart failure, vasopressin antagonist
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LixivaptanDrug
Capsules containing 25, or 50 mg doses of oral lixivaptan to be administered BID or QD Lixivaptan will be administered for 12 weeks in the Open-Label Period which will be followed by a 4 week Randomized, Placebo-Controlled period.
| Study group | Role | What they receive |
|---|---|---|
| Placebo QD or BID | Placebo comparator | Placebo QD or BID Receives: Drug: Lixivaptan |
| Lixivaptan QD or BID | Experimental | Lixivaptan QD or BID Receives: Drug: Lixivaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo during the 4 week double blind treatment period.
Measured: 12 weeks
Secondary outcomes (1)
To demonstrate that after 12 weeks of open-label lixivaptan treatment, improvements in the time to complete the Trail Making Test (Part B) will be maintained in patients continuing to receive lixivaptan.
Measured: 20 weeks
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 startJul 2009
- Primary completionAug 2010 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: Created Extension study - This study was no longer feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypervolemic 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
- None (open label)
- Enrolment
- 300 participants (estimated)
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
- NCT00876876
- Sponsor's protocol ID
- CK-LX3422
- Status last verified
- Nov 2010
- First submitted
- 3 Apr 2009
- Last updated
- 23 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia
- ClinicalTrials.gov ID
- NCT00876876
- Acronym / sponsor ID
- CK-LX3422
- Conditions
- Hypervolemic Hyponatremia
- Keywords
- hypervolemic hyponatremia, serum sodium, fluid overload, heartfailure, acute heart failure, vasopressin antagonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Created Extension study - This study was no longer feasible
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- CardioKine Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cardiokine Biopharma, LLC, Biogen
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- 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.
To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo during the 4 week double blind treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo QD or BID | Placebo comparator | Drug: LixivaptanPlacebo QD or BID |
| Lixivaptan QD or BID | Experimental | Drug: LixivaptanLixivaptan QD or BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and Women with age greater than or equal to 18 years.
- Prior successful participation in a randomized, blinded, placebo-controlled Phase 3 lixivaptan study of hyponatremia in Heart Failure (Protocol CK-LX3401) with evidence of continued need for therapy as follows:
- The patient has clinical evidence of volume overload with at least one of the following:
Key exclusion criteria (6 listed)
- Women who are pregnant (positive pregnancy test), breastfeeding or who will not adhere to the reproductive precautions as outlined in this protocol and in the informed consent form.
- Inability to provide informed consent.
- Acute severe hyponatremia with overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
- Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state).
- Hyponatremia in hypovolemic states. Hypovolemia is defined as the presence of clinical evidence of fluid volume depletion.
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 containing 25, or 50 mg doses of oral lixivaptan to be administered BID or QD Lixivaptan will be administered for 12 weeks in the Open-Label Period which will be followed by a 4 week Randomized, Placebo-Controlled period. | Drug | Lixivaptan QD or BID, Placebo QD or BID |
Primary outcome
To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo during the 4 week double blind treatment period.
Time frame: 12 weeks
1 secondary outcome
To demonstrate that after 12 weeks of open-label lixivaptan treatment, improvements in the time to complete the Trail Making Test (Part B) will be maintained in patients continuing to receive lixivaptan.
Time frame: 20 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
Related trials for Hypervolemic Hyponatremia
RecruitingObservational study
Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial
Non-hypervolemic Hyponatremia
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lixivaptan in people with Hypervolemic Hyponatremia, run by CardioKine Inc..
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 11 inclusion and 6 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: withdrawn, as of the sponsor's last update on 23 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 after 12 weeks of open-label lixivaptan treatment, serum sodium is maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo during the 4 week double blind treatment period. (time frame: 12 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 23 Nov 2010.