Terlipressin For HRS-AKI In Liver Transplant Candidates (INFUSE) (INFUSE)

Overview

About this study

The purpose of this study is to assess safety/effectiveness for continuous terlipressin infusion adult subjects on the liver transplant wait list with Hepatorenal syndrome- Acute Kidney Injury (HRS-AKI).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Written informed consent by subject or legally authorized representative.
  • At least 18 years of age.
  • Cirrhosis and ascites.
  • No sustained improvement in renal function (less than 20% decrease in SCr) at least 48 hours after diuretic withdrawal and after plasma volume expansion with albumin (given daily for two days - 48 hours minimum from 1st dose).
  • Increase in SCr by at least ≥ 0.3 mg/dl OR 1.5-2 fold above baseline (AKI stage 1 and above), to a SCr of ≥ 1.5 mg/dl at the time of initiating treatment. Baseline SCr is defined as the most recent, lowest SCr within last 6 months before date of current admission.
  • On liver transplant wait list or liver transplant eligible with anticipation of being placed on the liver transplant wait list within seven days of screening.

Exclusion Criteria:

  • Serum creatinine level greater than 7.0 mg/dL.
  • Uncontrolled sepsis and/or uncontrolled bacterial infection (e.g., persisting bacteremia, persisting ascitic fluid leukocytosis, fever, increasing leukocytosis with vasomotor instability).
  • Shock.
  • Current or recent (within 4 weeks) treatment with or exposure to nephrotoxic agents: eg, aminoglycosides, amphotericin, cyclosporine A, cisplatin, nonsteroidal anti-inflammatory drugs (NSAIDs: e.g., ibuprofen, naproxen, diclofenac), significant exposure to radiographic contrast agents (large doses or multiple injections of iodinated contrast media; e.g., during coronary or abdominal angiogram).
  • Estimated life expectancy of less than 7 days.
  • Superimposed acute liver injury due to drugs (e.g., acetaminophen), dietary supplements, herbal preparations, viral hepatitis, or toxins (e.g., Amanita toxin with mushroom poisoning carbon tetrachloride), with the exception of acute alcoholic hepatitis.
  • Evidence of obstructive uropathy or parenchymal renal disease. Renal ultrasound or other imaging not required but should be taken if suspicious.
  • Tubular epithelial casts, heme granular casts (range of 1-3 granular casts acceptable), hematuria or microhematuria on urinalysis that is indicative of acute tubular necrosis and/or intrinsic renal disease.
  • Subjects known to be pregnant; all women of child-bearing age and potential must have a negative pregnancy test.
  • Severe cardiovascular disease, including, but not limited to, unstable angina, pulmonary edema, congestive heart failure, or persisting symptomatic peripheral vascular disease, myocardial infarction or stable chronic angina within the past 12 months, or any other cardiovascular disease judged by the investigator to be severe and creates a risk to subject with concurrent terlipressin use.
  • Current or recent (within 4 weeks) renal replacement therapy (RRT) or anticipation of RRT within 3 days on enrollment.
  • Participation in other clinical research involving investigational medicinal products that would adversely affect participation in this or the current trial.
  • Transjugular intrahepatic portosystemic shunt (TIPS) within 30 days of starting study drug.
  • Ongoing use of vasopressors. Any vasopressors must be stopped prior to treatment with terlipressin in the Prospective Terlipressin Group and also were not concomitantly taking any norepinephrine or vasopressors during the two weeks prior to treatment with terlipressin.
  • Known allergy or sensitivity to terlipressin.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Douglas Simonetto, M.D.

Closed for enrollment

Contact information:

Amy Olofson

5075386547

olofson.amy@mayo.edu

More information

Publications

Publications are currently not available