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A Study Comparing Human Albumin and Saline Solution for Treating Kidney Injury in Patients with Advanced Liver Cirrhosis

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What is this study about?

This study involves patients with decompensated cirrhosis, which is a serious liver condition where the liver can no longer perform its normal functions properly, and acute kidney injury, which means the kidneys suddenly stop working as they should. The condition being studied is specifically when the kidney injury reaches a certain level of severity called AKI 1B or greater. The study will compare two different treatments: human serum albumin, which is a protein naturally found in blood that is given through a vein, and sodium chloride solution, which is a salt water solution also given through a vein. Human serum albumin can help maintain blood volume and pressure in the body, while sodium chloride solution is commonly used to provide fluids to patients.

The purpose of this study is to find out whether human serum albumin works better than sodium chloride solution in helping the kidneys recover in patients who have both liver cirrhosis and kidney injury. The study will look at how many patients in each treatment group have their kidney function return to normal levels, which is measured by checking certain substances in the blood. The researchers will also examine whether the treatment helps patients avoid needing kidney replacement therapy, which is a treatment that does the work of the kidneys when they are not functioning properly.

During the study, patients will receive either human serum albumin or sodium chloride solution through an infusion into a vein over a period of two days. The study is described as open-label, which means both the patients and doctors will know which treatment is being given. The researchers will monitor various health measurements throughout the study, including blood tests to check kidney function, measurements of inflammation in the body, heart function using ultrasound images, and overall survival. The study will also track any unwanted effects that may occur during treatment. Patients will be followed for 28 days to see how well their kidneys recover and how their overall health progresses.

1 Initial assessment and treatment assignment

Upon joining the study, your medical condition will be assessed. The study focuses on decompensated liver cirrhosis, which is a condition where the liver has severe scarring and is not functioning properly, along with acute kidney injury (sudden decrease in kidney function).

You will be assigned to receive either human serum albumin (a protein found naturally in blood) or sodium chloride 0.9% (a salt solution, also called saline). The assignment will be determined randomly.

If you are a woman who could become pregnant, a pregnancy test will be performed before you join the study. You will need to use effective birth control methods during the study, such as an intrauterine device, partner vasectomy, or complete avoidance of sexual intercourse. Hormonal birth control methods should be avoided due to potential effects on liver function.

2 Treatment administration

You will receive your assigned treatment through intravenous infusion, which means the medication will be given directly into your vein.

The treatment will consist of either human serum albumin or sodium chloride 0.9% solution, depending on your assigned group.

The medication will be administered as a solution for infusion through an intravenous line.

3 Regular monitoring visits

You will attend multiple scheduled visits during the study period. These visits are numbered as visit 1, visit 2, visit 4, visit 5, visit 6, visit 7, and a visit at day 28.

During these visits, blood and urine samples will be collected to measure various substances that help assess your kidney function, inflammation levels, and other health indicators.

Your kidney function will be monitored by measuring serum creatinine, a waste product in the blood that indicates how well your kidneys are working.

Blood tests will measure inflammation markers in your body, including substances called cytokines (proteins that affect the immune system) such as TNFα, IL-6, IL-8, IL-10, IL-1β, IFN-ɣ, G-CSF, VCAM, and VEGF.

Additional blood and urine markers will be measured, including copeptin, NGAL, PD-L1, and L-FABP, which help predict kidney function outcomes.

Blood samples will also measure hormones that affect blood pressure and fluid balance, including plasma renin and copeptin.

4 Heart function assessment

You will undergo echocardiographic examinations, which are ultrasound tests of your heart, at specific visits: visit 1, visit 2, visit 7, and at day 28.

These tests will measure how your heart is functioning and moving blood through your body.

5 Assessment of kidney injury improvement

Your kidney function will be evaluated to determine if there is improvement in the acute kidney injury.

The main measure of success is whether your kidney function returns to normal, defined as your serum creatinine level decreasing by less than 0.3 mg/dL compared to the starting level, without needing renal replacement therapy (a treatment that performs kidney functions artificially, such as dialysis).

The medical team will also assess whether your kidney injury grade improves during the study period.

6 Monitoring for side effects

Throughout the study, you will be monitored for any unwanted effects or complications related to the treatment.

Any adverse events will be recorded and assessed for their severity and relationship to the study treatment.

7 Follow-up through day 28

The study will continue to monitor your health status through day 28 after starting treatment.

Your survival and overall health outcomes will be assessed at this timepoint.

If you require renal replacement therapy at any point, this will be documented.

Who Can Join the Study?

  • You must be 18 years old or older.
  • You must have cirrhosis, which is scarring of the liver. This can be confirmed through standard medical examination, ultrasound images, or tissue examination. Cirrhosis from any cause can be included.
  • You must have acute kidney injury (sudden decrease in how well your kidneys work) of stage 1B or higher, as defined by European medical guidelines.
  • If you are a woman who can become pregnant, you must have a negative pregnancy test in your blood before joining the study.
  • If you are a woman who can become pregnant, you must agree to use highly effective birth control methods during the study. These methods include: a device placed in the uterus to prevent pregnancy, having both fallopian tubes blocked or closed, having a partner who has had surgery to prevent pregnancy, or not having sexual intercourse with men for twelve months. Birth control pills and hormones will not be used in this study because they may harm liver function.

Who Cannot Join the Study?

  • The source data does not provide specific exclusion criteria for this clinical trial
  • Please note that this study involves patients with decompensated hepatic cirrhosis, which means the liver is not working properly and cannot perform its normal functions
  • The study focuses on patients with AKI (acute kidney injury), which is a sudden decrease in how well the kidneys work
  • Without detailed exclusion criteria listed in the provided information, it is not possible to specify which patients cannot participate in this study

Where you can join this trial?

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Other Sites

Site Name City Country Status
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
03.11.2025

Trial locations

Investigated drugs:

Human albumin is a protein solution given through a vein that helps maintain fluid balance in the body. In this trial, it is being tested to see if it can help improve kidney function in patients with liver cirrhosis who have developed kidney problems.

Saline solution is a sterile salt water solution given through a vein that helps maintain hydration and fluid balance in the body. In this trial, it is being compared to human albumin to see which treatment works better for improving kidney function in patients with liver cirrhosis and kidney problems.

Investigated diseases:

Decompensated Hepatic Cirrhosis – Decompensated hepatic cirrhosis is an advanced stage of liver scarring where the liver can no longer perform its essential functions adequately. This condition develops when chronic liver disease progresses and the liver becomes severely damaged. Patients experience complications such as fluid accumulation in the abdomen, confusion due to toxins affecting the brain, bleeding from enlarged veins, and yellowing of the skin and eyes. The liver loses its ability to produce important proteins, remove harmful substances from the blood, and regulate fluid balance in the body. As the condition worsens, patients may develop kidney problems and other organ complications. This represents a critical phase of liver disease where the organ’s compensatory mechanisms have failed.

Acute Kidney Injury – Acute kidney injury is a sudden decline in kidney function that occurs over hours to days. The kidneys lose their ability to filter waste products and excess fluid from the blood effectively. This condition is characterized by a rapid increase in creatinine levels in the blood and often a decrease in urine output. Acute kidney injury can range from mild to severe and may occur in patients with various underlying conditions, including liver disease. The kidneys may struggle to maintain proper balance of electrolytes and fluids in the body. In severe cases, patients may require temporary support to replace kidney function until recovery occurs.

Trial ID:
2025-521457-16-00
Protocol code:
LIVER-AKI
Trial Phase:
Therapeutic confirmatory (Phase III)

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