Abstract: SA-OR014
Terlipressin and Kidney Replacement Therapy in Patients with Hepatorenal Syndrome-AKI Ineligible for Liver Transplantation: An Exploratory Subgroup Analysis of the CONFIRM Trial
Session Information
- AKI Trials, Therapeutics, and Risk Stratification
October 24, 2026 | Location: Room 603, Convention Center
Abstract Time: 05:10 PM - 05:20 PM
Category: Acute Kidney Injury
- 102 AKI: Clinical, Outcomes, and Trials
Authors
- Regner, Kevin R., Medical College of Wisconsin, Milwaukee, Wisconsin, United States
- Reau, Nancy, Rush University Medical Center, Chicago, Illinois, United States
- Patidar, Kavish Rohit, Houston Methodist Hospital, Houston, Texas, United States
- Larson, Laurie, University of Minnesota Physicians, Minneapolis, Minnesota, United States
- Gilles, HoChong S., Central Virginia VA Health Care System, Richmond, Virginia, United States
- Ufere, Nneka, Massachusetts General Hospital, Boston, Massachusetts, United States
- Shah, Anooj, formerly affiliated with Mallinckrodt Hospital Products, Inc. (A Keenova Therapeutics Company), Bridgewater, New Jersey, United States
- Wu, Richard, Mallinckrodt Hospital Products, Inc. (A Keenova Therapeutics Company), Bridgewater, New Jersey, United States
- White, Chris, Mallinckrodt Hospital Products, Inc. (A Keenova Therapeutics Company), Bridgewater, New Jersey, United States
- Frederick, Richard Todd, California Pacific Medical Center, San Francisco, California, United States
Background
Hepatorenal syndrome-acute kidney injury (HRS-AKI) is a functional renal failure resulting from hemodynamic changes occurring in patients (pts) with ascites and portal hypertension. HRS-AKI standard of care is vasoconstrictor therapy, with terlipressin recommended as the only FDA-approved treatment for adults with HRS with rapid reduction in kidney function. Liver transplant (LT) is the definitive treatment for decompensated cirrhosis, but some pts are ineligible. Here, we analyzed potential benefit of terlipressin in pts ineligible for LT using data from the phase 3 CONFIRM (NCT02770716) trial.
Methods
In CONFIRM, pts were randomized 2:1 to terlipressin+albumin or placebo (PBO)+albumin. This exploratory analysis evaluated efficacy and safety of terlipressin in the overall LT-ineligible population and an LT-ineligible subpopulation excluding pts with SCr ≥5 mg/dL and/or ACLF grade 3. The primary endpoint from CONFIRM (verified HRS reversal), safety, and renal replacement therapy (RRT) incidence in pts alive from Day (D) 14-90 were analyzed.
Results
Of 300 pts in CONFIRM (n=199 terlipressin, n=101 PBO), 108 were LT-ineligible (n=71 terlipressin, n=37 PBO); of those, 73 were in the subpopulation (n=45 terlipressin, n=28 PBO). Percentage of pts with verified HRS reversal was higher for terlipressin vs PBO in all populations (CONFIRM, 29.1% vs 15.8%; LT-ineligible, 28.2% vs 16.2%; subpopulation, 35.6% vs 17.9%, respectively). RRT incidence was lower as early as D14 and up to D90 with terlipressin vs PBO (Figure). No unique safety signals were observed in the LT-ineligible population and subpopulation compared to the overall CONFIRM population.
Conclusion
In this exploratory analysis, pts ineligible for LT receiving terlipressin vs PBO had reduced RRT incidence at D14-90. RRT incidence may be attributed to individual treatment decisions, particularly in this population. HRS-AKI–related outcomes with terlipressin were similar regardless of transplant eligibility. Safety aligned with the overall CONFIRM population.
Funding
- Commercial Support – Keenova Therapeutics Company