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Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE)
NCT04460560 · View on ClinicalTrials.gov ↗
Study Summary
Hepatorenal syndrome-acute kidney injury (HRS-AKI), a potentially reversible renal failure, is a serious, rapidly progressing, often fatal, complication of decompensated cirrhosis. Terlipressin is a synthetic vasopressin analogue that acts as a systemic vasoconstrictor via the vascular vasopressin V1 receptors. In HRS-AKI patients the strong V1 receptor-mediated vasoconstrictor activity of terlipressin, particularly in the splanchnic area, increases effective intravascular volume and mean arterial pressure (MAP), ameliorates renin-angiotensin-aldosterone system and sympathetic nervous system hyperactivity, and improves renal blood flow. The INFUSE trial will evaluate the use of continuous terlipressin infusion in patients on the liver transplant waiting list with HRS-AKI.
Conditions Studied
Interventions
- DRUG Terlipressin
Study Locations (7)
California
- California Pacific Medical Center — San Francisco
Georgia
- Piedmont Healthcare, Inc — Atlanta
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
Minnesota
- Mayo Clinic — Rochester
Pennsylvania
- University of Pennsylvania — Philadelphia
Tennessee
- Vanderbilt University Medical Center — Nashville
Texas
- Baylor Scott and White All Saints Medical Center — Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-12-11 |
| Est. Completion | 2023-12-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04460560
The ClinicalTrials.gov registry entry for NCT04460560 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hepatorenal Syndrome appearing as the primary indexed condition, and to 1 intervention — of which Terlipressin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04460560 reports 7 study locations spanning 7 distinct geographic areas — top geographies include California, Georgia, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04460560 about?
NCT04460560 is a clinical study titled "Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE)". Hepatorenal syndrome-acute kidney injury (HRS-AKI), a potentially reversible renal failure, is a serious, rapidly progressing, often fatal, complication of decompensated cirrhosis. Terlipressin is a synthetic vasopressin analogue that acts as a systemic vasoconstrictor via the vascular vasopressin V...
What is the current status of trial NCT04460560?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2020-12-11. Estimated completion is 2023-12-27.
What conditions does trial NCT04460560 study?
This clinical trial studies the following conditions: Hepatorenal Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04460560?
The interventions under investigation include: Terlipressin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04460560?
This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04460560 being conducted?
This trial has 7 study locations across California, Georgia, Massachusetts, Minnesota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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