Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

Phase 3

Completed

• Conditions: Hepatorenal Syndrome
• Interventions: Drug: terlipressin; Drug: Placebo

• 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

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-08-06
• Study First Submitted QC: 2004-08-06
• Study First Posted: 2004-08-09
• Primary Completion: 2006-03
• Study Completion: 2006-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

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)

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

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