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Abstract: TH-PO037

Impact of Hepatorenal Syndrome (HRS) Reversal on the Need for Renal Replacement Therapy (RRT): Analysis From 3 Phase 3 Terlipressin Studies

Session Information

Category: Acute Kidney Injury

  • 102 AKI: Clinical‚ Outcomes‚ and Trials

Authors

  • Mujtaba, Muhammad Ahmad, The University of Texas Medical Branch at Galveston Development Office, Galveston, Texas, United States
  • Gamilla-Crudo, Ann Kathleen N., The University of Texas Medical Branch at Galveston Development Office, Galveston, Texas, United States
  • Merwat, Shehzad Nawaz, The University of Texas Medical Branch at Galveston Development Office, Galveston, Texas, United States
  • Kueht, Michael, The University of Texas Medical Branch at Galveston Development Office, Galveston, Texas, United States
  • Karim, Aftab, University of Illinois Chicago College of Medicine, Chicago, Illinois, United States
  • Khattak, Muhammad Waqar, University of Illinois Chicago College of Medicine, Chicago, Illinois, United States
  • Zafar, Zunaira, St. Mary Medical Center, Langhorne, Pennsylvania, United States
  • Jamil, Khurram, Mallinckrodt LLC, Clinton, New Jersey, United States
Background

HRS is a progressive but potentially reversible kidney failure in patients (pts) with advanced cirrhosis. RRT is offered if pts fail pharmacotherapy; however, it is an invasive and costly intervention associated with increased morbidity in some pts. Terlipressin (Terli) is the standard-of-care treatment for pts with HRS based on the current US and European guidelines.

Methods

Data from 3 Phase 3, placebo (Pbo)-controlled clinical studies (OT-0401, REVERSE, and CONFIRM) were pooled (N=608) for subgroup analyses. Associations between HRS reversal—defined as at least 1 serum creatinine (SCr) value of ≤1.5 mg/dL while on treatment—and the need for RRT, overall and per treatment, were examined up to 90 days.

Results

By Day 90, 209 pts had received RRT (Terli, n=111; Pbo, n=98). Baseline characteristics were similar between treatment groups and typical of pts with advanced cirrhosis: mean (SD) MELD scores were 33.6 (6.4) and 33.2 (6.0) in the Terli and Pbo groups, respectively. Overall, HRS reversal was associated with a reduced need for RRT (Table). In pts who achieved HRS reversal, RRT incidence was similar between treatment groups. Yet, among nonresponders (ie, no HRS reversal), there was still a lower incidence of RRT in pts treated with Terli vs Pbo (Table). Mean (SD) changes in SCr from baseline to end of treatment among nonresponders were 0.1 (1.3) mg/dL in the Terli group vs 0.6 (1.4) in the Pbo group; P<.001.

Conclusion

This analysis evaluated the largest database of pts with HRS treated with Terli. Improved renal function resulted in a decreased need for RRT. Even among nonresponders, changes in renal function were significantly better in the Terli group vs the Pbo group and, therefore, Terli reduced the need for RRT in these pts vs Pbo.

Table. Incidence of RRT through Day 90 for patients alive at landmark time points

Funding

  • Commercial Support –