A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1

Study start date: June 1, 2004

Inclusion Criteria: * Chronic, or acute liver disease * Rapidly progressive reduction in renal function, e.g. doubling of serum creatinine to \>2.5 mg/dL in less than two weeks. * No sustained improvement in renal function after diuretic withdrawal and plasma volume expansion * Proteinuria \<500 mg per day * No evidence of granular casts in urinalysis or ultrasonographic evidence of obstructive uropathy or parenchymal renal disease Exclusion Criteria: * Ongoing shock * Uncontrolled bacterial infection * Current significant fluid losses * Current or recent treatment with nephrotoxic drugs (e.g. NSAIDs or aminoglycosides within 4 weeks) * Acute liver disease due to factors known to be also directly nephrotoxic (e.g. acetaminophen overdose) * Confirmed pregnancy * Severe cardiovascular disease * Evidence of intrinsic or parenchymal renal disease (e.g. acute tubular necrosis) * Participation in other clinical studies within 30 days