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

CardioKine Inc.135 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

135

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Torrance Clinical Research

Lomita, California, United States

Innovative Research of West Florida

Clearewater, Florida, United States

Fleming Island Center for Clinical Research

Fleming Island, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.