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Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome

NCT06256432 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

DRUG

Ambrisentan

Endothelin receptor antagonist

DRUG

Terlipressin

Terlipressin

Sponsors & Collaborators

  • Noorik Biopharmaceuticals AG

    lead INDUSTRY

Principal Investigators

  • Iker Navarro, MD · Noorik Biopharmaceuticals AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-17
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06256432 on ClinicalTrials.gov