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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic hyponatremia

Condition or disease
Hyponatremia With Normal Extracellular Fluid Volume; Hyponatremia With Excess Extracellular Fluid Volume

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

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Study Type :	Observational
Actual Enrollment :	135 participants
Observational Model:	Cohort
Time Perspective:	Cross-Sectional
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
Study Start Date :	January 2010
Actual Primary Completion Date :	June 2011

Groups and Cohorts

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Group/Cohort
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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

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. [ Time Frame: 28 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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)

Criteria

Inclusion Criteria:

1. Men and women 18 years of age or older
2. Ability to provide informed consent or assent
3. Prior participation in a lixivaptan hyponatremia trial with evidence of continued need or desire for therapy

Exclusion Criteria:

1. A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient
2. Hyponatremia which is acute, reversible, artificial or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy
3. Hyponatremia due to reversible medical condition or therapy
4. Conditions associated with an independent imminent risk of morbidity and mortality

Contacts and Locations

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Locations

United States, California
Torrance Clinical Research
Lomita, California, United States, 90717
United States, Florida
Innovative Research of West Florida
Clearewater, Florida, United States, 33756
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States, 32003
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
United States, Missouri
Millenium Psychiatric Associates, LLC
Creve Cour, Missouri, United States, 63141
United States, Nebraska
Internal Medical Associates of Grand Island, PC
Grand Island, Nebraska, United States, 68803

Sponsors and Collaborators

CardioKine Inc.

Cardiokine Biopharma, LLC

Biogen

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Cesare Orlandi, MD, Cardiokine Biopharma, LLC
ClinicalTrials.gov Identifier:	NCT01056848 History of Changes
Other Study ID Numbers:	CK-LX3431
First Posted:	January 26, 2010
Last Update Posted:	June 21, 2011
Last Verified:	June 2011

Keywords provided by CardioKine Inc.:

Euvolemic Hyponatremia; Hypervolemic Hyponatremia; SIADH; Serum Sodium

Additional relevant MeSH terms:

Hyponatremia; Water-Electrolyte Imbalance; Metabolic Diseases