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Kidney Week

Abstract: FR-OR01

Terlipressin Improves Renal Replacement Therapy–Free Survival in Hepatorenal Syndrome Type 1

Session Information

Category: Acute Kidney Injury

  • 102 AKI: Clinical, Outcomes, and Trials

Authors

  • Velez, Juan Carlos Q., Ochsner Health System, New Orleans, Louisiana, United States
  • Befeler, Alex, Saint Louis University, Saint Louis, Missouri, United States
  • Kurtz, Ira, UCLA Medical Center, Los Angeles, California, United States
  • Gallegos-Orozco, Juan F., University of Utah Health, Salt Lake City, Utah, United States
  • Vargas, Hugo E., Mayo Clinic, Phoenix, Arizona, United States
  • Vierling, John M., Baylor College of Medicine, Houston, Texas, United States
  • Pappas, S. Chris, Orphan Therapeutics, Lebanon, New Jersey, United States
  • Jamil, Khurram, Mallinckrodt Pharmaceuticals Specialty Brands Principal Office, Bedminster, New Jersey, United States
Background

Hepatorenal syndrome type 1 (HRS-1) is an ominous form of acute kidney injury in patients with cirrhosis. Recently, the results of the randomized placebo (PBO)-controlled trial (RCT) CONFIRM demonstrated that terlipressin (TERLI) is effective in reversing HRS-1 and in reducing the cumulative need for renal replacement therapy (RRT). However, whether TERLI reduces the need for RRT among survivors has not been determined.

Methods

CONFIRM (NCT02770716) was a North American RCT (n=300) that compared HRS-1 reversal rates between patients treated with albumin plus TERLI (n=199) or albumin plus PBO (n=101) (2:1). We conducted a post hoc intention-to-treat analysis to assess the incidence of RRT among CONFIRM survivors. We also conducted a pooled analysis of the 3 TERLI RCTs in HRS-1 (OT-0401 [NCT00089570], REVERSE [NCT01143246], and CONFIRM) to examine 90-day RRT-free survival rates.

Results

In CONFIRM, the cumulative incidences of need for RRT for TERLI at day 14, 30, and 90 were 23%, 26%, and 29% compared with 35%, 36%, and 39% for patients assigned to PBO (P=0.03, 0.07, and 0.1, respectively). Among survivors, significantly fewer TERLI-treated patients remained dependent on RRT at day 14, 30, and 90 (22%, 26%, and 30%, respectively) compared with PBO (39%, 43%, and 46%; P<0.01, P=0.03, and P=0.05, respectively). The 90-day RRT-free survival rate was 35% in the TERLI group vs 30% in the PBO group (P=0.08), with a numerically longer median number of days in the TERLI group (20 vs 11). Pooled analysis of the 3 RCTs revealed a greater 90-day RRT-free survival rate for TERLI-treated (n=352) compared with PBO-treated (n=256) patients (37% vs 29%, P=0.03; OR [95% CI], 1.47 [1.04, 2.07]).

Conclusion

Treatment with TERLI added to albumin decreased the rate of RRT and improved RRT-free survival in patients with HRS-1. This is the first pharmacological intervention proven to reduce the need for RRT in patients with HRS-1. Because of the significant impact of RRT on quality of life, this observation expands the clinical benefit of TERLI and enhances the reported efficacy of TERLI in inducing HRS-1 reversal.