River2Renal: Phase 2 R2R01 Plus Terlipressin Versus Terlipressin with Hepatorenal Syndrome – AKI

A clinical trial is testing whether adding an experimental drug called R2R01 to the standard treatment terlipressin can reverse a life-threatening form of kidney failure that strikes people with advanced liver disease. This condition, hepatorenal syndrome with acute kidney injury (HRS-AKI), occurs when liver cirrhosis causes blood vessels in the kidneys to constrict, starving them of blood flow. Standard treatment with terlipressin alone often fails, and patients frequently die or require a liver transplant. The study aims to find out whether R2R01—which likely works by a different mechanism to improve kidney blood flow—can boost the success rate of terlipressin. If the combination proves more effective, it could offer a new treatment option for a condition with few alternatives. The trial is structured in three parts: an initial open-label phase to test different R2R01 doses alongside terlipressin, followed by a blinded placebo-controlled phase to rigorously compare the combination against terlipressin alone, and an open-label phase for patients who did not respond to terlipressin. Success could mean fewer patients progressing to dialysis or needing urgent liver transplantation, directly improving survival and quality of life for people with end-stage liver disease.