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. Men and Women with age greater than or equal to 18 years. 2. Baseline Serum sodium concentration =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous participation in this or any other lixivaptan clinical trial. 2. Participation in any other investigational study of drugs or devices within 30-Days prior to Screening. 3. Women who will not adhere to the reproductive precautions as outlined in section 4.3 of the protocol and in the informed consent form. 4. Positive urine pregnancy test. 5. Inability to provide informed consent. 6. Inability to respond to thirst. 7. Inability to take oral medications. 8. Acute severe hyponatremia. 9. Overt symptoms of hyponatremia requiring immediate medical intervention (e.g., severe lethargy, coma, seizures). 10. Hemodynamically significant uncorrected primary cardiac valvular disease. 11. Hypertrophic cardiomyopathy (obstructive or non-obstructive). 12. CHF due to uncorrected thyroid disease (i.e., T4 above or below the limits of the reference range), active myocarditis or known amyloid cardiomyopathy. 13. History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator. 14. ST-segment elevation myocardial infarction (STEMI) within 30-Days or active myocardial ischemia at the time of enrollment. 15. History of stroke within 30-Days prior to screening. 16. History of a cardiac revascularization procedure within 30-Days prior to screening. 17. Subjects who are on cardiac mechanical support. 18. History of bi-ventricular pacer placement within the last 30-Days. 19. Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, ultrafiltration or dialysis, or other cardiac surgery within 30 days following study enrollment. 20. Serum creatinine > 3.0 mg/dL/265.2 mol/L. 21. Uncontrolled diabetes mellitus as defined by the Investigator (e.g. HbA1c > 9%). 22. Adrenal insufficiency, whether treated or not. If serum cortisol is less than the lower limit of the reference range, the patient is excluded and should be referred for follow-up evaluation. 23. History of primary significant liver disease or acute hepatic failure, as defined by the Investigator. 24. History of chronic drug/medication abuse within the 6 months, or current alcohol abuse. 25. Co-morbid condition with an expected survival less than six months. Specific requirements for females Women of child-bearing potential must demonstrate a negative urine pregnancy test prior to randomization and at the final study visit 30 days after the last dose of study drug. In addition, women of child-bearing potential must agree to use one of the methods of birth control detailed in 4.3 of the protocol for the entire study period including screening, the titration and treatment phases and the 30-day follow-up period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine whether administration of lixivaptan can effectively and safely produce an increase in serum sodium from Baseline in HF patients with volume overload and hyponatremia.;Secondary Objective: The secondary objectives of this study are that lixivaptan: a. Demonstrates improvement in serum sodium concentrations (AUC) up to Day 60 within the double-blind on-therapy period for hyponatremic patients with serum sodium <135 mEq/L at Baseline. b. Is associated with improvement in clinical status as measured by: i. Changes in the Trail Making Test, part B following 28 days of dosing. ii. Days alive and out of the hospital (for cardiovascular causes) within 60-Days of randomisation. c. Prevents worsening of hyponatremia d. Improves the percentage of patients with normalized serum sodium.;Primary end point(s): The change from baseline in serum sodium concentrations at day 7 of the double-blind on-therapy period for hyponatremic patients with serum sodium of <135 mEq/L at baseline. | — |
Countries
Czech Republic, Germany, Italy, Spain
Outcome results
None listed