Subjects with 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 (refer to section 12.4 of the protocol for definition of women to be included in the trial and 12.4.1 for acceptable methods of contraception) 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., lethargy, coma, seizures) 3. Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state) 4. Hyponatremia in hypovolemic states. Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion 5. Pseudohyponatremia (i.e., hyponatremia due to a laboratory artifact) 6. Hypertonic hyponatremia (hyponatremia in the setting of hyperglycemia) 7. Hyponatremia as a result of any medication that can safely be withdrawn 8. Hyponatremia due to hypothyroidism or adrenal insufficiency 9. Current diagnosis of psychogenic polydipsia 10. Receiving within 7 days of enrollment, other medication for treatment of hyponatremia specifically: demeclocycline, lithium carbonate, urea, or any vasopressin antagonist 11. Use of radiotherapy and/or chemotherapy within 2 wks of randomization 12. Serum creatinine >3.0 mg/dL (265.2 mol/L) 13. Uncontrolled diabetes mellitus as defined by the Investigators (e.g. HbA1c > 9%) 14. Severe pulmonary artery hypertension: subjects whose condition is expected to deteriorate 15. Established diagnosis of New York Heart Association (NYHA) class III or IV heart failure 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. Significant neurological impairment such that the subject would not be able to complete study procedures. (Examples of neurological conditions which could exclude subjects 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) 19. Conditions limiting access to water or an inability to respond to thirst (e.g., hydrophobia or non-communicative) 20. Established diagnosis of nephrotic syndrome 21. Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis 22. Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive) 23. History of chronic drug/medication abuse within the past 6 months or current alcohol abuse 24. Terminally ill or moribund condition with little chance of short-term survival 25. Receiving vasopressin or its analogs for treatment of any condition 26. Known allergy to any vasopressin antagonist 27. Previous participation in a lixivaptan study 28. Recipient of any investigational treatment (drug or device) within 30 days prior to baseline visit 29. Unable to take oral medications
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. The change in the serum sodium level at day 7 as the single primary endpoint will be analyzed.;Primary end point(s): The change from Baseline in serum sodium concentration at day 7 of the double-blind on-therapy period for hyponatremic subjects with serum sodium <130 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 30 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 of study. 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 30 | — |
Countries
Belgium, Germany
Outcome results
None listed