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

Completed

• Conditions: Hyponatremia With Normal Extracellular Fluid Volume; Hyponatremia With Excess Extracellular Fluid Volume

• Registration Number: NCT01056848
• Lead Sponsor: CardioKine Inc.

Brief Summary

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Last Update Submitted: 2011-06-20
• Last Update Posted: 2011-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Innovative Research of West Florida; 🇺🇸 Clearewater, Florida, United States

Torrance Clinical Research; 🇺🇸 Lomita, California, United States

Fleming Island Center for Clinical Research; 🇺🇸 Fleming Island, Florida, United States

Internal Medical Associates of Grand Island, PC; 🇺🇸 Grand Island, Nebraska, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Millenium Psychiatric Associates, LLC; 🇺🇸 Creve Cour, Missouri, United States