Study on the Effects of Camostat Mesilate for Kidney Protection in Patients with Chronic Kidney Disease and Proteinuria

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Camostat Mesilate on individuals with Chronic Kidney Disease (CKD) who also have proteinuria, which means there is an excess of protein in their urine. The purpose of the study is to evaluate how Camostat Mesilate affects the body’s ability to excrete salt and water, as well as its impact on total body water content and blood pressure in patients with CKD compared to healthy individuals.

Participants in the study will take Camostat Mesilate in the form of a tablet. The study will monitor various health indicators, including urine sodium and water excretion, body weight, and blood pressure at home. Additionally, the study will look at urine protease activity, which involves enzymes that break down proteins, and other markers in the urine and blood that can provide insights into kidney function and health.

The study will take place over a period of time, with participants being closely monitored to understand the effects of the medication. The goal is to gather information that could help improve treatment options for people with CKD. Participants will be required to maintain their usual antihypertensive treatment, which is medication to manage high blood pressure, throughout the study. The study is expected to conclude by the end of 2025.

1 joining the study

Upon joining the study, you will be required to provide a signed informed consent. This confirms your understanding of the study and your willingness to participate.

You must meet certain criteria, such as being over 18 years old, having a clinical diagnosis of chronic kidney disease (CKD) with specific kidney function and protein levels, and maintaining stable blood pressure.

2 initial assessments

Initial assessments will be conducted to establish baseline measurements. These include checking your blood pressure, evaluating your kidney function, and measuring protein levels in your urine.

Women of childbearing potential will undergo a pregnancy test and must use contraception during the study and for one week after completing the study treatment.

3 medication administration

You will begin taking the study medication, camostat mesilate, which is administered orally. The specific dosage and frequency will be provided by the study team.

It is important to take the medication as directed and maintain your current antihypertensive treatment throughout the study.

4 ongoing monitoring

Throughout the study, regular monitoring will occur to assess the effects of the medication. This includes measuring urine sodium and water excretion, body weight, and home blood pressure.

Additional tests may include urine and blood samples to evaluate various biological markers related to kidney function and overall health.

5 completion of study

At the end of the study, final assessments will be conducted to compare with initial measurements. This helps determine the effect of the medication on your kidney function and overall health.

You will be informed about the study’s findings and any relevant information regarding your health.

Who Can Join the Study?

Must be over 18 years old.
Must have a clinical diagnosis of Chronic Kidney Disease (CKD) with the following conditions at screening:
- eGFR (estimated Glomerular Filtration Rate) greater than 30 ml/min/1.73m². This is a test to check how well your kidneys are working.
- U-ACR (Urine Albumin-to-Creatinine Ratio) greater than 300 mg/g. This measures protein in your urine.
Must have stable treatment for high blood pressure for at least 2 weeks before starting the study medication and continue this treatment during the study.
Blood pressure at the screening visit should be more than 120/70 mmHg and less than 150/90 mmHg.
Must be able to provide signed consent and follow study requirements.
Women who can become pregnant must have a negative pregnancy test at the screening visit and use birth control during the study and for one week after the study treatment ends.

Who Cannot Join the Study?

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a known allergy to Camostat mesilate (the medication being studied).
Patients who are unable to follow the study procedures or instructions.
Patients with a history of drug or alcohol abuse within the past year.
Patients with uncontrolled high blood pressure.
Patients with severe liver disease.
Patients with a history of heart attack or stroke within the last 6 months.
Patients who are currently taking medications that might interfere with the study drug.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Odense University Hospital	Odense	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.08.2024

Trial locations

Investigated drugs:

CAMOSTAT MESILATE

Camostat mesilate is a medication being studied for its potential to protect the kidneys in people with chronic kidney disease. It works by affecting how the body handles salt and water, which can influence blood pressure and the amount of water in the body. The goal of using this medication in the trial is to see if it can help improve kidney function and manage these factors in patients compared to healthy individuals.

Investigated diseases:

Chronic Kidney Disease with proteinuria – Chronic Kidney Disease (CKD) is a long-term condition characterized by a gradual loss of kidney function over time. In CKD with proteinuria, there is an abnormal presence of protein in the urine, indicating kidney damage. As the disease progresses, the kidneys become less effective at filtering waste and excess fluids from the blood. This can lead to a buildup of waste products in the body, causing symptoms such as fatigue, swelling, and high blood pressure. Over time, the condition can lead to complications such as anemia, bone disease, and cardiovascular issues. Proteinuria is a key marker of kidney damage and can accelerate the progression of CKD.

Trial ID:

2023-508516-34-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Camostat Mesilate for Kidney Protection in Patients with Chronic Kidney Disease and Proteinuria

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