Placebo-Controlled Randomized Study of KW-3902 for Subjects Hospitalized With Worsening Renal Function and Heart Failure Requiring IV Therapy

Exclusion Criteria

• •IV radiographic contrast within 14 days
• •IV vasodilators within 6 hours
• •Serum potassium \<3.5 meq/L
• •Ongoing or planned therapy for heart failure with mechanical circulatory or ventilatory support
• •Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis
• •Rapidly progressive acute renal failure
• •Evidence of acute tubular necrosis or post-obstructive nephropathy or other exogenous causes of acute kidney injury, unrelated to heart failure
• •Severe pulmonary disease
• •Significant stenotic mitral or aortic valvular disease
• •Heart transplant recipient or admitted for cardiac transplantation or LVAD surgery
• •Any major surgery within 2 weeks prior
• •evidence of acute coronary syndrome in the 2 weeks prior
• •Hgb \<8 g/dL, Hct \<25%, or active bleeding requiring transfusion
• •Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy.
• •Known hepatic impairment
• •Non-cardiac pulmonary edema
• •Temperature \>38°C
• •Sepsis or active infection requiring IV anti-microbial treatment
• •Administration of an investigational drug or device within 30 days
• •Current or anticipated therapy with atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole
• •Administration of any vasopressor or inotropic drug within 72 hours
• •History of seizure (except febrile seizure)
• •Stroke within 2 years
• •History of brain tumor of any etiology
• •Brain surgery within 2 years
• •Encephalitis/meningitis within 2 years
• •History of penetrating head trauma
• •Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years
• •History of or at risk for alcohol withdrawal seizures
• •Advanced Alzheimer's disease
• •Advanced multiple sclerosis