NCT06256432

Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome

A Multi-Centre, Randomised, Open-Label, Phase II Study of Ambrisentan in Patients With Hepatorenal Syndrome

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Noorik Biopharmaceuticals AG · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patients with advanced cirrhosis of the liver develop kidney problems occasionally. This condition is called Hepatorenal Syndrome, requires hospitalization and frequently results in death. The goal of this clinical trial is to test whether the administration of low doses of ambrisentan can help patients with Hepatorenal Syndrome and to determine if it is safe. Ambrisentan is a drug that is approved for the treatment of high blood pressure in the lungs at higher doses. This clinical trial will compare the safety and effects of ambrisentan to another drug called terlipressin, which is commonly used to treat patients with hepatorenal syndrome. The main questions the clinical trial aims to answer are: * Does ambrisentan help the kidney function of the patient? * Does ambrisentan help prevent death in patients with Hepatorenal Syndrome? * Does ambrisentan prevent Hepatorenal Syndrome from reappearing? While in the hospital, trial participants will receive either one of two doses of ambrisentan or terlipressin. If in the first 4 days, ambrisentan is not helpful, the patient may be eligible to receive terlipressin. Patients assigned to receive ambrisentan will continue taking this medication at home after leaving the hospitals and until they complete 60 days of treatment.

Conditions

• Hepatorenal Syndrome
• Liver Cirrhosis
• Acute Kidney Injury
• Ascites Hepatic

Interventions

Type	Name	Description
DRUG	Ambrisentan	Endothelin receptor antagonist
DRUG	Terlipressin	Terlipressin

Timeline

• Start date: 2024-04-17
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2024-02-13
• Last updated: 2026-04-13

Locations

6 sites across 1 country: India