Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatorenal Syndrome

In brief

This study is to treat adult patients with hepatorenal syndrome (HRS) Type 1. Out of every three participants, two will receive terlipressin and one will receive placebo. Assignments will be made randomly.

Key facts

Study ID

NCT02770716

Run by

Mallinckrodt

People needed

300

Starts

2016-07-13

Expected to finish

2019-07-24

Last updated by the study team

2022-11-29

Who can join

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

You may qualify if…

• Written informed consent by participant or legally authorized representative
• Cirrhosis and ascites
• Rapidly progressive worsening in renal function to a serum creatinine (SCr) at least 2.25 mg/dL and meeting a trajectory for SCr to double over 2 weeks
• No sustained improvement in renal function (less than 20% decrease in SCr and SCr at least 2.25 mg/dL) at least 48 hours after diuretic withdrawal and the beginning of plasma volume expansion with albumin
• Discontinues midodrine and octreotide before randomization if applicable

You may not qualify if…

• Serum creatinine level greater than 7.0 mg/dL
• At least 1 event of large volume paracentesis (LVP) at least 4 L within 2 days of randomization
• Sepsis and/or uncontrolled bacterial infection
• Less than 2 days anti-infective therapy for documented or suspected infection
• Shock
• Being treatment with or exposure to nephrotoxic agents, nonsteroidal anti-inflammatory drugs, or significant radiographic contrast agents (within the last 4 weeks)
• Estimated life expectancy of less than 3 days
• Superimposed acute liver injury due to drugs, dietary supplements, herbal preparations, viral hepatitis, or toxins, with the exception of acute alcoholic hepatitis
• Proteinuria greater than 500 mg/day
• Evidence of obstructive uropathy or parenchymal renal disease on ultrasound or other imaging
• Tubular epithelial casts, heme granular casts, hematuria or microhematuria (greater than 50 red blood cells per high power field in the absence of recent catheterization) on urinalysis
• Pregnancy; all women of child-bearing age and potential must have a negative pregnancy test
• Cardiovascular disease judged by the investigator to be severe
• Current or recent renal replacement therapy (RRT) within the past 4 weeks
• Participation in other clinical research involving investigational medicinal products within 30 days of randomization
• Transjugular intrahepatic portosystemic shunt (TIPS) within 30 days of randomization
• Use of vasopressors for at least 3 consecutive days within the 14-day screening period - patients receiving any vasopressor other than midodrine and octreotide within 24 hours of qualifying SCr are also excluded, ie, a 24-hour washout is required prior to enrollment
• Known allergy or sensitivity to terlipressin or another component of the study treatment

Where it is running

• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• Mayo Clinic - AZ — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• USC Healthcare — Los Angeles, California, United States
• Stanford Hospital and Clinics — Palo Alto, California, United States
• UCLA Medical Center — San Diego, California, United States
• Southern California Research Center — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Mayo Clinic - FL — Jacksonville, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Tampa General Medical Group — Tampa, Florida, United States
• Piedmont Hospital Transplant — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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