Euvolemic hyponatremia MedDRA version: 9.1 Level: LLT Classification code 10021038 Term: Hyponatremia
Conditions
Sponsors
Cardiokine Biopharma, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent. 2. Men or women aged 18 or older. 3. Diagnosis of euvolemic hyponatremia (Na+=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed. 2. Overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures). 3. Acute or transient hyponatremia (e.g., associated with head trauma, postoperative state, or use of radiotherapy and/or chemotherapy). 4. Hyponatremia in hypovolemic states (e.g., due to fluid loss through vomiting, diarrhea, burns, etc.). Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion. 5. Hyponatremia in hypervolemic states (e.g., congestive heart failure). Hypervolemia is defined as a presence of increased total body water with signs of edema. 6. Pseudohyponatremia (i.e., hyponatremia resulting from a laboratory artifact). 7. Hypertonic hyponatremia (e.g., hyponatremia in the setting of hyperglycemia). 8. Hyponatremia as a result of any medication that can safely be withdrawn. 9. Hyponatremia due to hypothyroidism or adrenal insufficiency. 10. Current diagnosis of psychogenic polydipsia. 11. Receiving within 7 days of enrollment other medication for treatment of hyponatremia, specifically: demeclocycline, lithium carbonate, urea, or any vasopressin antagonist. 12. Supine systolic arterial blood pressure of = 90 millimeters of mercury (mmHg). 13. Serum creatinine > 3.0 mg/dL (> 265.2 mol/L). 14. Hypokalemia based on clinical sign/symptoms or lab findings (e.g., serum potassium 9%). 16. ST-segment elevation myocardial infarction (STEMI) within 30 days or active myocardial ischemia at the time of enrollment. 17. History of cerebral vascular accident (CVA) within 30 days prior to screening. 18. Severe malnutrition in the Investigator’s judgment (e.g., body mass index [BMI] < 17). 19. Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis. 20. Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive). 21. History of chronic drug/medication abuse within the past 6 months or current alcohol abuse. 22. Terminally ill or moribund condition with little chance of short-term survival. 23. Receiving vasopressin or its analogs for treatment of any condition. 24. Known allergy to any vasopressin antagonist. 25. Previous participation in a lixivaptan study. 26. Recipient of any investigational treatment within 30 days prior to baseline visit. 27. Unable to take oral medications. 28. Significant neurological impairment such that the subject would not be able to complete the procedures. (Examples of neurological conditions which could exclude subject from participating, include but are not limited to Alzheimer’s disease, normal pressure hydrocephalus, Parkinsonian dementia complex, multi-infarct dementia, mixed dementia, or Huntington’s disease). 29. Conditions limiting access to water or an inability to respond to thirst (e.g., hydrophobia, or non-communicative).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that lixivaptan is safe and effective in achieving and maintaining increased serum sodium concentration in subjects with syndrome of inappropriate antidiuretic hormone secretion (SIADH) and other conditions of euvolemic hyponatremia. Efficacy will be assessed as change from baseline in serum sodium on Day 7 of the double-blind on-therapy period for hyponatremic subjects with serum sodium < 135 mEq/L at baseline.;Secondary Objective: The secondary objectives of this study are to determine whether lixivaptan administration demonstrates improvement in: 1. Serum sodium concentrations (AUC) up to Day 28 within the double-blind on-therapy period. 2. Percentage of subjects achieving normalized serum sodium (Na+ = 135 mEq/L and = 145 mEq/L). 3. Percentage of subjects requiring fluid restriction at any time during the treatment period. 4. Prevention of worsening of hyponatremia. 5. The change from baseline in the recorded time to complete the Trail Making Test, Part B (TMT-B) at Day 28.;Primary end point(s): Change from baseline in serum sodium on Day 7. | — |
Countries
Belgium, Czech Republic, Germany, Italy
Outcome results
None listed