drugset / Trial / NCT04460560

Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE)

NCT04460560

Phase 3 Completed 50 enrolled University of Pennsylvania
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-12-11
Primary completion
2023-12-27
Completion
2023-12-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Terlipressin Peptide 0.5 mg Intravenous

Indications