A study to evaluate the effectiveness and safety of ursodeoxycholic acid in patients with hepatorenal polycystic diseases.

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What is this study about?

This study focuses on Hepatorenal polycystic diseases, which are conditions where fluid-filled sacs, known as cysts, grow in both the liver and the kidneys. The goal of the research is to evaluate the effectiveness and safety of ursodeoxycholic acid compared to a placebo in slowing the growth of these cysts in the liver.

During the study, participants will be monitored to see how the medication affects the size of the liver and kidney cysts, as well as overall organ function. This includes checking renal function, which refers to how well the kidneys filter waste from the blood, and monitoring liver profile markers through blood tests to ensure safety. Researchers will also look at genetic information and certain proteins or molecules in the blood, often called biomarkers, to better understand how the disease progresses and how individuals respond to the treatment.

Who Can Join the Study?

You must be between 18 and 80 years old.
You must have a diagnosis of liver disease or hepatorenal polycystic disease, which is a condition where fluid-filled sacs called cysts grow in both the liver and the kidneys.
Your total liver volume, which is the total size or amount of space your liver takes up, must be between 2000 and 5000 mL.
To meet the criteria for polycystic liver disease (PLD), you must have more than 10 cysts in your liver.
To meet the criteria for polycystic kidney disease (PKD), the number of cysts required depends on your age: at least 2 kidney cysts (or 1 cyst in each kidney) if you are under 30; at least 2 cysts in each kidney if you are between 30 and 59; or at least 4 cysts in each kidney if you are 60 or older.
You must not be a candidate for aspiration (a procedure where a needle is used to drain fluid from a cyst) or surgical intervention (an operation) at the time you join the study.

Who Cannot Join the Study?

If the total volume of liver cysts (fluid-filled sacs in the liver), known as TLV, is greater than 5000 mL.
Having a chronic liver disease (a long-term liver problem) that is not caused by polycystic liver disease (PLD).
Having undergone any aspiration (using a needle to drain fluid) or surgical intervention (surgery) within the last 6 months.
Having used somatostatin analogues (medicines that mimic a natural hormone to slow certain processes) within the last 6 months.
Having an allergy or hypersensitivity (an extreme reaction) to UDCA (the study medication).
Having galactose intolerance (the inability to digest a specific sugar), malabsorption (the body’s inability to absorb nutrients properly), or lactase deficiency (the inability to digest the sugar found in milk).
Having acute cholecystitis (sudden inflammation of the gallbladder) or frequent episodes of biliary colic (sudden pain caused by gallstones).
Having used tolvaptan (a medication used for certain kidney or liver conditions) within the last 6 months.
Having renal dysfunction (kidney problems), specifically a GFR (a measure of how well the kidneys filter blood) of 30 ml/min/1.73m2 or less.
Using hormonal contraceptives (birth control pills) or estrogen supplements within the last 6 months.
Participating in another clinical trial (a medical research study) at the same time as this one.
Being pregnant or lactating (breastfeeding), or being able to become pregnant without using an effective form of contraception (birth control).
Having any other serious illness or health condition that makes the doctor believe it is unsafe to participate.
Having gastric ulcers (sores in the stomach) or duodenal ulcers (sores in the first part of the small intestine).
Using medicines that may interfere with the study drug, such as cholestyramine or aluminum hydroxide.
Having used UDCA (the study medication) within the last 6 months.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hnrjmlqu Uclyzqbtbifzt Dtedselm	Donostia / San Sebastian	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.11.2025

Trial locations

Investigated drugs:

Ursodeoxycholic Acid

Ursodeoxycholic acid is a medication used in this study to see if it can help slow down the growth of cysts in the liver for people with certain genetic liver diseases.

Investigated diseases:

Hepatorenal polycystic diseases – This is a group of genetic conditions that cause multiple fluid-filled sacs, known as cysts, to grow in both the liver and the kidneys. As the condition progresses, the number and size of these cysts increase over time. This growth can lead to an enlargement of the total volume of both the liver and the kidneys. The expansion of these organs may eventually affect how well the liver and kidneys function.

Trial ID:

2024-513644-28-00

Protocol code:

URSOPOL

Trial Phase:

Therapeutic exploratory (Phase II)

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A study to evaluate the effectiveness and safety of ursodeoxycholic acid in patients with hepatorenal polycystic diseases.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?