Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1
- Registration Number
- NCT00089570
- Lead Sponsor
- Mallinckrodt
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Terlipressin terlipressin Terlipressin Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Treatment Success Day 14
- Secondary Outcome Measures
Name Time Method Renal function and survival Renal funtion to Day 14 and Survival to Day 180
Trial Locations
- Locations (37)
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Medicine & Dentistry of New Jersey - NJMS
🇺🇸Newark, New Jersey, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center of Dallas
🇺🇸Dallas, Texas, 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
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
University of Colorado Hospital & Health Sciences Center
🇺🇸Denver, Colorado, United States
VA CT Health Care System
🇺🇸West Haven, Connecticut, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Fairview-University Medical Center
🇺🇸Minneapolis, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Weill Cornell Medical Center
🇺🇸New York, New York, United States
Center for Liver Disease & Transplantation Clinic
🇺🇸New York, New York, United States
Mount Sinai Medical Center/Mount Sinai Hospital
🇺🇸New York, New York, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
St. Luke's Episcopal Hospital, St. Luke's Texas Liver Institute
🇺🇸Houston, Texas, United States
VCU Medical Center
🇺🇸Richmond, Virginia, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of Arizona College of Medicine
🇺🇸Tucson, Arizona, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Georgetown University Hospital
🇺🇸Washington, D.C., District of Columbia, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
983285 Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States