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

NCT01056848 | Completed

• 1 other identifier: CK-LX3431
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Hyponatremia With Normal Extracellular Fluid Volume; Hyponatremia With Excess Extracellular Fluid Volume

Keywords

Euvolemic Hyponatremia; Hypervolemic Hyponatremia; SIADH; Serum Sodium

Outcome Measures

Primary Outcomes (1)

• To assess the safety of long-term lixivaptan use in patients who were previously enrolled in one of the 3 Phase III trials.

  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.

  28 weeks

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CardioKine Inc.: lead
• Cardiokine Biopharma, LLC: collaborator
• Biogen: collaborator

Study Sites (6)

Torrance Clinical Research

Lomita, California, 90717, United States

Location

Innovative Research of West Florida

Clearewater, Florida, 33756, United States

Location

Fleming Island Center for Clinical Research

Fleming Island, Florida, 32003, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Millenium Psychiatric Associates, LLC

Creve Cour, Missouri, 63141, United States

Location

Internal Medical Associates of Grand Island, PC

Grand Island, Nebraska, 68803, United States

Location

MeSH Terms

Conditions

Inappropriate ADH Syndrome

Condition Hierarchy (Ancestors)

Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 26, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Last Updated: June 21, 2011

Record last verified: 2011-06

Locations

US (6)