Terlipressin in Combined Hepatorenal Syndrome in Patients With Signs of Chronic Renal Disease

NCT06161766 | Completed FDA Drug

• 1 other identifier: Terli-CKD
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this retrospective study is to evaluate the treatment response to terlipressin and albumin in patients with suspicion of HRS-AKI and signs of chronic parenchymal kidney disease (HRS-AKI-like syndrome) compared to patients without signs of chronic parenchymal kidney disease (HRS-AKI).

Conditions

Liver Cirrhosis; Hepato-Renal Syndrome; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Complete response to treatment with vasoactive drugs and albumin at the end of treatment

  Complete response, as defined by a decrease of serum creatinine (SCr) to a value within 0.3 mg/dl (26.5 µmol/L) of the baseline value, at the end of vasoactive treatment.

  Through study completion, an average of 12 months

Secondary Outcomes (10)

• Complete response to treatment with vasoactive drugs and albumin during follow-up

  Through study completion, an average of 12 months

• Transplantation-free survival

  Through study completion, an average of 12 months

• Partial response, at the end of vasoactive treatment

  Through study completion, an average of 12 months

• In-hospital mortality

  Through study completion, an average of 12 months

• 90-day survival

  Within 90 days after beginning of hospitalization

Study Arms (1)

Patients with HRS-AKI or HRS-AKI-like syndrome and chronic kidney disease

Patients with clinical suspicion of HRS-AKI or HRS-AKI-like syndrome in case of previously diagnosed chronic kidney disease (CKD) who who receive vasoactive treatment for the management of HRS, as defined by the administration of terlipressin or noradrenalin plus albumin.

Drug: terlipressin or noradrenalin plus albumin

Interventions

terlipressin or noradrenalin plus albumin DRUG

Patients with clinical suspicion of HRS-AKI or HRS-AKI-like syndrome in case of previously diagnosed CKD who had received vasoactive treatment for the management of HRS, as defined by the administration of terlipressin or noradrenalin plus albumin.

Patients with HRS-AKI or HRS-AKI-like syndrome and chronic kidney disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed liver cirrhosis with ascites due to portal hypertension and 3) Clinical suspicion of HRS-AKI or HRS-AKI-like syndrome are included in this study. HRS-AKI-like syndrome is defined as typical features of HRS but wuth pre-existing chronic kidney disease.

You may qualify if:

• Patients with cirrhosis confirmed by histology or liver stiffness or with unequivocal signs in ultrasound, endoscopy and/or blood tests hospitalized between 1st of January 2018 and 31st of December 2022.
• Evidence of ascites due to portal hypertension
• Clinical suspicion of HRS-AKI or HRS-AKI-like syndrome (in case of previously diagnosed CKD)
• Pre-existing data on kidney function (SCr and eGFR) minimum 3 months prior to admission in a stable situation
• Dip stick urine test results (screening for proteinuria and hematuria) before initiation of AKI-treatment
• Vasoactive treatment for the management of HRS-AKI, as defined by the administration of terlipressin or noradrenalin plus albumin
• Age ≥ 18 years old

You may not qualify if:

• Uncontrolled shock
• Patients with cardiac cirrhosis as defined by the development of cirrhosis in a patient with chronic heart failure due to a primary cardiac disease (ischemic cardiomyopathy, hypertensive cardiomyopathy, etc.)
• Patients with hepatocellular carcinoma BCLC C or D
• Patients receiving renal replacement therapy at baseline

Sponsors & Collaborators

• University Hospital Freiburg: lead
• Jena University Hospital: collaborator
• Johannes Gutenberg University Mainz: collaborator
• University Hospital Muenster: collaborator

Study Sites (4)

University Medical Center Freiburg

Freiburg im Breisgau, Germany

Location

University Medical center Jena

Jena, Germany

Location

University Medical Center Mainz

Mainz, Germany

Location

University Hospital Münster

Münster, Germany

Location

Related Publications (1)

• Uschner FE, Schleicher EM, Passenberg M, Pohl J, Praktiknjo M, Volk AT, Karbannek H, Chang J, Grosse K, Rohrer C, Labenz C, Maasoumy B, Jamme P, von Widdern JC, Queck A, Trebicka J, Engelmann C, Rashidi-Alavijeh J, Bettinger D, Ripoll C; German Cirrhosis Study Group. Chronic Kidney Disease Does Not Influence Response to Terlipressin in Hepatorenal Syndrome-Acute Kidney Injury. Clin Gastroenterol Hepatol. 2025 Nov 19:S1542-3565(25)00989-9. doi: 10.1016/j.cgh.2025.11.006. Online ahead of print.

  PMID: 41265546 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Hepatorenal Syndrome; Renal Insufficiency, Chronic

Interventions

Terlipressin; Albumins

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Cristina Ripoll, MD

  University Hospital Jena

  PRINCIPAL INVESTIGATOR

• Dominik Bettinger, MD

  University Hospital Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Principal Investigator

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 8, 2023
• Study Start: March 3, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)