A Study to Confirm the Effectiveness and Safety of Terlipressin for Treatment of Hepatorenal Syndrome Type 1

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-004633
    • Rochester, Minnesota: 16-004633
    NCT ID: NCT02770716
    Sponsor Protocol Number: MNK19013058

About this study

The purpose of this study is to confirm the effectiveness and safety of  terlipressin in the treatment of adult patients with hepatorenal syndrome (HRS) type 1.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Adults with cirrhosis and ascites
  • Rapidly progressive worsening in renal function to a serum creatinine ≥ 2.25 mg/dL
  • No sustained improvement in renal function (< 20% decrease in SCr and SCr ≥2.25 mg/dL) at least 48 hours after diuretic withdrawal and the beginning of plasma volume expansion with albumin

Exclusion Criteria

  • Serum creatinine level > 7.0 mg/dL
  • At least 1 event of large volume paracentesis (LVP) ≥ 4 L within 2 days of randomization
  • Sepsis and/or uncontrolled bacterial infection
  • < 2 days anti-infective therapy for documented or suspected infection
  • Shock
  • Current or recent (within 4 weeks) treatment with or exposure to nephrotoxic agents
  • Superimposed acute liver injury due to drugs (e.g., acetaminophen), dietary supplements, herbal preparations, viral hepatitis, or toxins
  • Proteinuria > 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
  • Confirmed pregnancy
  • Severe cardiovascular disease, including, but not limited to, unstable angina, pulmonary edema, congestive heart failure
  • Current or recent (within 4 weeks) renal replacement therapy
  • Participation in other clinical research involving investigational medicinal products within 30 days of randomization

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Open for enrollment

Contact information:

Jill Weidknecht MBA/HCM, R.N.

(480)342-3007

Weidknecht.Jill@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Open for enrollment

Contact information:

Sarah Wilder R.N.

(507)284-2698

Wilder.Sarah@mayo.edu