Defining Renal Recovery in Patients With Hepatorenal Syndrome‐Acute Kidney Injury: Experience From North American Studies

ABSTRACT Introduction The degree of improvement in serum creatinine (SCr) has previously been suggested as a sensitive indicator of treatment response in patients with hepatorenal syndrome‐acute kidney injury (HRS‐AKI), while HRS reversal remains the primary endpoint in clinical trials. Methods A to...

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Bibliographic Details
Published in:JGH open 2024-12, Vol.8 (12), p.e70058-n/a
Main Authors: Mujtaba, Muhammad A., Elsiesy, Hussien, Faiz, Sara, Hussain, Syed A., Gamilla‐Crudo, Ann Kathleen N., Karim, Aftab, Khan, Mohammad Irfan, Khattak, Muhammad Waqar, Zafar, Zunaira, Kueht, Michael, Jamil, Khurram
Format: Article
Language:English
Subjects:
Demographics
Kidneys
Liver cirrhosis
Medical prognosis
Original
Population
Transplants & implants
Variance analysis
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Summary:ABSTRACT Introduction The degree of improvement in serum creatinine (SCr) has previously been suggested as a sensitive indicator of treatment response in patients with hepatorenal syndrome‐acute kidney injury (HRS‐AKI), while HRS reversal remains the primary endpoint in clinical trials. Methods A total of ≥ 30% SCr improvement was analyzed as an exploratory prespecified endpoint in the CONFIRM trial. In this post hoc analysis, intent‐to‐treat population data from three Phase 3 studies (OT‐0401, REVERSE, and CONFIRM) conducted in North America in patients with HRS‐AKI were pooled to assess the incidence of > 30% improvement in SCr and its association with clinical outcomes. Results Significantly more patients treated with terlipressin achieved > 30% improvement in SCr compared with those who received a placebo (42.9% vs. 23.4%; p  30% improvement in SCr, those who achieved this threshold had a lower incidence of renal replacement therapy (RRT) (55.2% vs. 14%, respectively; p 
ISSN:2397-9070
2397-9070
DOI:10.1002/jgh3.70058