Mallinckrodt to Present New Terlipressin Data at Kidney Week 2025 for Hepatorenal Syndrome Treatment
核心洞察
Mallinckrodt will present two poster studies on TERLIVAZ (terlipressin) at Kidney Week 2025, examining the effects of paracentesis and chronic kidney disease (搜索) in HRS-AKI patients.
The presentations include a post hoc analysis of the Phase III CONFIRM trial and real-world outcomes data from the Premier U.S. hospital database.
TERLIVAZ remains the first and only FDA-approved treatment for hepatorenal syndrome (搜索) with rapid kidney function decline, affecting over 60,000 Americans annually.
Mallinckrodt plc announced it will present two poster studies on terlipressin (TERLIVAZ) for hepatorenal syndrome (搜索)-acute kidney injury (搜索) (HRS-AKI) at the American Society of Nephrology's Kidney Week 2025 meeting in Houston, Texas, from November 5-9, 2025.
The presentations will examine factors that may impact treatment outcomes in HRS-AKI patients receiving terlipressin, including the effects of paracentesis procedures and pre-existing chronic kidney disease (搜索) (CKD).
Clinical Research Presentations
The first poster, "Association of Paracentesis with Hepatorenal Syndrome (搜索) (HRS) Reversal: Insights from the CONFIRM Trial of Terlipressin," represents a post hoc analysis of the Phase III CONFIRM clinical trial. The study assessed the impact of paracentesis, a procedure to relieve intra-abdominal pressure that may improve renal hemodynamics, in HRS-AKI patients treated with terlipressin. Paracentesis was recorded from treatment initiation up to 14 days or until at least one serum creatinine value ≤1.5 mg/dL while on treatment ≤24 hours after the last dose of study drug was recorded.
The second poster, "Impact of CKD on Real-World Outcomes in Patients Treated with Terlipressin for HRS-AKI," examined a real-world cohort identified from the Premier U.S. hospital database using ICD-10, drug, and billing codes. The study assessed how pre-existing CKD impacts real-world treatment outcomes in adult patients hospitalized with HRS-AKI and treated with terlipressin, comparing patient characteristics and key clinical outcomes between those with and without CKD.
Treatment Landscape for Rare Condition
TERLIVAZ (terlipressin) for injection is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function. HRS is estimated to affect more than 60,000 Americans annually, approximately 0.01% of the U.S. population, making it a rare condition, and rates of HRS hospitalizations are increasing.
"The poster presentations at this year's ASN Annual Meeting aim to help expand our knowledge of the potential factors impacting appropriate HRS-AKI patients treated with TERLIVAZ, like pre-existing CKD or undergoing paracentesis," said Christopher White, M.D., M.S.P.H., Senior Director, Hepatology Lead, Clinical Development and Medical Affairs, Mallinckrodt. "The more clinical data and real-world experience available, the better, which helps to support our understanding of appropriate patients who are most likely to benefit from TERLIVAZ treatment."
Disease Burden and Prognosis
Hepatorenal syndrome (搜索) is a life-threatening condition that occurs in people with advanced liver disease (搜索). HRS is classified into two distinct types – a rapidly progressive type that leads to renal failure where patients are typically hospitalized for their care (HRS-acute kidney injury (搜索)) and a more chronic type that progresses slowly over weeks to months (HRS-chronic kidney disease (搜索)). If left untreated, HRS-AKI has a median survival time of less than two weeks and greater than 80% mortality at three months.
Safety Profile and Limitations
TERLIVAZ carries a boxed warning for serious or fatal respiratory failure (搜索), with patients with volume overload or acute-on-chronic liver failure Grade 3 at increased risk. The drug is contraindicated in patients experiencing hypoxia or worsening respiratory symptoms and in patients with ongoing coronary, peripheral, or mesenteric ischemia. Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit from treatment.
The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure (搜索), diarrhea, and dyspnea.