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Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00089570
Recruitment Status : Completed
First Posted : August 9, 2004
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatorenal Syndrome Drug: terlipressin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1
Study Start Date : June 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Terlipressin
Terlipressin
 Drug: terlipressin
Placebo Comparator: Placebo
Placebo
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Success [ Time Frame: Day 14 ]

Secondary Outcome Measures :
  1. Renal function and survival [ Time Frame: Renal funtion to Day 14 and Survival to Day 180 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089570


Locations
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Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Chair: Arun J. Sanyal, M.D. Medical College of Virginia, Virginia Commonwealth University Medical Center
Study Director: Thomas D. Boyer, M.D. University of Arizona Health Sciences Center
Study Director: Peter Teuber, Ph.D. Orphan Therapeutics
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00089570    
Other Study ID Numbers: OT-0401
First Posted: August 9, 2004    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Keywords provided by Mallinckrodt:
hepatorenal syndrome
terlipressin
Additional relevant MeSH terms:
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Hepatorenal Syndrome
Syndrome
Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
 Kidney Diseases
Urologic Diseases
Terlipressin
Antihypertensive Agents
Vasoconstrictor Agents