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Could a lung drug save kidneys in liver patients?

NCT ID NCT06256432

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether ambrisentan, a drug approved for lung blood pressure, can help patients with hepatorenal syndrome—a serious kidney problem that can occur in advanced liver cirrhosis. About 54 hospitalized adults will receive either ambrisentan or the standard drug terlipressin. The goal is to see if ambrisentan improves kidney function and reduces death risk, with treatment continuing at home for up to 60 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ambrisentan
What this could lead to
If it works, this could offer a new treatment option for hepatorenal syndrome, potentially improving kidney function and survival in patients with advanced liver disease.
What could go wrong
This is an early Phase 2 trial with only 54 participants, so results may not apply to everyone. Ambrisentan may not work better than the current standard treatment, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written Informed consent prior to any study-related procedures. * Age ≥ 18 years and ≤ 70 years. * Male or non-pregnant, non-lactating female. Women of child-bearing potential must have a confirmed negative serum pregnancy test at the time of screening and must use a highly effective contraceptive method throughout the study such as combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tube occlusion, vasectomised partner, and sexual abstinence and until one month after completing treatment with the study medication. In the case of hormonal contraception, women should have been on a stable regimen for a minimum of three months before study enrolment. Women not of child-bearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy). Men must use an effective contraception method (i.e., condom + diaphragm/spermicidal gel or foam, or vasectomy), and should not donate semen during the study. Men are considered to be fertile from the time of puberty, except for those men with permanent sterility secondary to bilateral orchiectomy. * Cirrhosis of the liver by laboratory examination, clinical history or biopsy. * History of ascites. * Increase in serum creatinine ≥ 0.3 mg/dl (26.5 µmol/L) from a value obtained in the 7 days prior to admission, OR a serum creatinine ≥ 1.5 mg/dl (132.6 µmol/L) and is ≥ 1.5-fold above the most recent and lowest value obtained in the last 3 months. * The subject has no clinical and/or haemodynamic evidence of intravascular volume depletion; or has undergone at least 12 hours of diuretic withdrawal and fluid resuscitation to discard or treat intravascular volume depletion (such as difficulty in establishing volume status, volume status is assessed as equivocal, or there is clinical and/or haemodynamic evidence of intravascular volume depletion), and no significant improvement in serum creatinine has been observed. Exclusion Criteria: * Serum creatinine \> 5 mg/dL (442 µmol/L). * Mean arterial pressure (MAP) \< 60 mmHg. * Large Volume Paracentesis (LVP) in the 3 days prior to screening. * Sepsis, uncontrolled bacterial infection or less than 2 days anti-infective therapy for documented or suspected bacterial infection. * Total bilirubin \> 8 mg/dL (137 µmol/L). * Serum sodium \< 125 mmol/L. * International Normalised Ratio (INR) ≥ 3.5. * Proteinuria ≥ 1000 mg/dL. * Microhaematuria \> 50 red blood cells per high power field. * Clinically significant casts on urinalysis, including granular casts. * History or evidence of obstructive uropathy or parenchymal renal disease on ultrasound or other imaging. * Subject with a recent history of circulatory shock defined as MAP \< 60 mmHg within 5 days prior to screening requiring vasopressors or subjects requires circulatory support with vasopressors during screening. * Subject requiring oxygen supplementation or mechanical ventilation. * Recent exposure to nephrotoxic agents or exposure to radiographic contrast agents within 72 hrs prior to screening. * Superimposed acute liver failure/injury due to factors other than alcohol, including acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom \[Amanita\] poisoning). * Severe cardiovascular disease, including, but not limited to, unstable angina, pulmonary oedema, congestive heart failure (NYHA ≥ II), or persisting symptomatic peripheral vascular disease, myocardial infarction or stable chronic angina within the past 12 months, or any other cardiovascular disease judged by the Investigator to be severe. * Subject has a history of Transjugular Intrahepatic Portosystemic shunt (TIPS). * Subject with acute variceal bleeding at the time of screening who may undergo pre-emptive TIPS or is anticipated to be treated with terlipressin. * Current or recent Renal Replacement Therapy (RRT) within 30 days of enrolment, or anticipation of RRT in the next 3 days after screening. * Hepatocellular Carcinoma (HCC) beyond the Milan criteria or other malignancy affecting survival beyond 6 months. * Participation in a study of an investigational medical product or device within the last 30 days preceding screening. * Hepatic Encephalopathy with West Haven Grade III or IV. * Current or recent (30 days prior to enrolment) treatment with endothelin receptor antagonists, including ambrisentan. * Estimated life expectancy of less than 3 days. * Known allergy or sensitivity to ambrisentan or propylene glycol. * History of Idiopathic Pulmonary Fibrosis. * Subject is unable or unwilling to follow instructions or comply with study procedures.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Asian Institute of Gastroenterology (AIG)

    Hyderabad, Telangana, 500082, India

  • Aster CMI Hospital

    Bangalore, Karnataka, 560092, India

  • Ganesh Shankar Vidyarthi Memorial (GSVM) Medical College

    Kanpur, Uttar Pradesh, 208002, India

  • Medanta Multi Super Specialty Hospital

    Lucknow, Uttar Pradesh, 226030, India

  • Sir HN Reliance Hospital Foundation

    Mumbai, Maharashtra, 400004, India

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