Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatorenal Syndrome

In brief

The purpose of this study is to determine whether terlipressin is safe and effective in the treatment of patients with hepatorenal syndrome (HRS) type 1 when compared to placebo.

Key facts

Study ID

NCT00089570

Run by

Mallinckrodt

People needed

112

Starts

2004-06-01

Expected to finish

2006-09-01

Last updated by the study team

2017-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• University of Arizona College of Medicine — Tucson, Arizona, United States
• UCLA School of Medicine — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• UCSD Medical Center Hillcrest — San Diego, California, United States
• VA Medical Center — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Colorado Hospital & Health Sciences Center — Denver, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• VA CT Health Care System — West Haven, Connecticut, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Fairview-University Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• 983285 Nebraska Medical Center — Omaha, Nebraska, United States
• University of Medicine & Dentistry of New Jersey - NJMS — Newark, New Jersey, United States
• Weill Cornell Medical Center — New York, New York, United States
• Mount Sinai Medical Center/Mount Sinai Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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