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Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 13, 2026 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 2025 to May 2026
    • Study completion date: Feb 2026 to Jun 2026
    • Site details revised at 6 of 6 sites
    v6
  2. Notable Primary completion date: Mar 2025 to Dec 2025v5 Show 4 more changesShow less
    • Enrollment target: 45 to 54
    • Study sites: 5 to 6
    • Study completion date: Jun 2025 to Feb 2026
    • Eligibility criteria shortened, about 52 words
  3. Minor Study sites: 3 to 5
    • Start date changed from estimate of Mar 2024 to Apr 17, 2024
    v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v3
  5. Minor Start date: Feb 2024 to Mar 2024v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06256432
Lead Sponsor Noorik Biopharmaceuticals AG
Conditions
(from sponsor)
Hepatorenal Syndrome, Liver Cirrhosis, Acute Kidney Injury, Ascites Hepatic
Related terms Acute Kidney Injury, Hepatorenal Syndrome, Liver Cirrhosis
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov