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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the effect of KW-3902IV, in addition to standard therapy, on the proportion of worsening heart failure and worsening renal function, and on the proportion of deaths or rehospitalizations for heart failure or worsening renal function, and to estimate and compare within-trial medical resource utilization and direct medical costs between subjects treated with KW 3902IV versus placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovaCardia, Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Rolofylline

Criteria

Inclusion Criteria:

• Dyspnea at rest or with minimal exertion at randomization

• Fluid overload

• Estimated creatinine clearance (CrCl) between 20-60 mL/min

• Worsening renal function

• Anticipated need for IV diuretic treatment for at least 48 hours after the start of study drug

• BNP >500 pg/mL or NT-pro-BNP >2000 pg/mL

• Systolic blood pressure ≥90 mmHg at randomization

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