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Abstract: TH-PO052

Improvement in Serum Creatinine Was Associated with Favorable Clinical Outcomes in Patients with Hepatorenal Syndrome: A Post Hoc Analysis of the CONFIRM Study

Session Information

Category: Acute Kidney Injury

  • 102 AKI: Clinical, Outcomes, and Trials


  • Velez, Juan Carlos Q., Ochsner Health, New Orleans, Louisiana, United States
  • Mujtaba, Muhammad Ahmad, The University of Texas Medical Branch at Galveston, Galveston, Texas, United States
  • Elsiesy, Hussien A., Baylor Scott & White Health, Plano, Texas, United States
  • Jamil, Khurram, Mallinckrodt plc, Dublin, Dublin, Ireland

Hepatorenal syndrome (HRS) is a life-threatening but potentially reversible form of acute kidney injury. More patients (pts) with HRS who were treated with terlipressin (terli), achieved verified HRS reversal than placebo (pbo) in the Phase III CONFIRM study (terli 29.1%; pbo 15.8%; P=.012). This post hoc analysis assessed pt data from CONFIRM to determine if an improvement in serum creatine (SCr) of >30% was associated with improved clinical outcomes.


CONFIRM enrolled adult pts with cirrhosis, ascites, HRS, and a SCr ≥2.25 mg/dL with a projected doubling in SCr within 2 weeks. Pts were treated intravenously with terli 1 mg every 6 hours or matched pbo; plus albumin, recommended. Pts from the CONFIRM intent-to-treat (ITT) population were analyzed by their improvement (>30% vs ≤30%) in SCr level from baseline (Day 0; or a prestudy value, if Day 0 value was missing) to the end of treatment (EOT) for the following: length of intensive care unit (ICU) stay; incidence of renal replacement therapy (RRT) and RRT-free survival at Days 30, 60 and 90; as well as survival at Day 90.


More pts in the terli vs pbo group had a >30% improvement in SCr from baseline to EOT (43.7% vs 21.8%; P<.001). Among pts admitted to the ICU, the mean (SD) length of stay was numerically shorter (5.8d [3.25] vs 9.4d [11.62]; P=.673) among those who had a >30% vs ≤30% improvement in SCr. Fewer pts in the >30% (vs ≤30%) improvement in SCr subgroup required RRT (Day 90: 18.3% vs 40.3%; P<.001). Overall, a higher proportion of pts (N=300; terli + pbo combined) who achieved >30% improvement in SCr were alive (67.0% vs 42.9%, P<.0001); and alive and RRT-free by Day 90 (55.0% vs 20.4%, P<.001) (Figure).


Significantly more pts in the terli group achieved a >30% improvement in SCr versus pbo. Pts with a >30% improvement in SCr had significant improvements in clinical outcomes through Day 90.