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Study on the Effects of Amiloride in Patients with Chronic Kidney Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Amiloride on individuals with Chronic Kidney Disease (CKD). The purpose of the study is to explore whether Amiloride can help protect kidney function and reduce the need for treatments like dialysis. Amiloride is a type of medication known as a diuretic, which helps the body get rid of excess salt and water. In this study, researchers are interested in seeing if Amiloride has additional benefits for the kidneys beyond its usual effects.

Participants in the study will receive either Amiloride or a placebo, which looks like the medication but does not contain any active ingredients. The study will involve taking the medication by mouth in the form of a tablet. Throughout the study, participants will have their kidney function monitored through urine tests and other assessments to see how the treatment affects their condition. The study aims to understand how Amiloride might influence certain proteins and inflammation in the kidneys, which are important factors in the progression of CKD.

The trial will help researchers learn more about the potential benefits of Amiloride for people with CKD and whether it can slow down the progression of the disease. By participating in this study, researchers hope to gather valuable information that could lead to better treatment options for individuals with chronic kidney disease in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, kidney function, and blood pressure levels.
A negative pregnancy test is required for women of childbearing potential, and contraception must be used during the study.
Step 2
Screening phase
The screening phase involves initial assessments to ensure all criteria are met. This may include blood pressure monitoring and kidney function tests.
If blood pressure is above the specified range, the screening phase may be extended to allow for stabilization.
Step 3
Medication administration
Participants receive either MODAMIDE 5 mg tablets containing amiloride hydrochloride dihydrate or a placebo.
The medication is taken orally as prescribed, with the dosage and frequency determined by the study protocol.
Step 4
Monitoring and assessments
Regular monitoring of kidney function and blood pressure is conducted throughout the study.
Urine samples are collected to measure specific markers such as urine C3a and urine soluble C5-9-sTCC/MAC.
Step 5
Evaluation of outcomes
The primary outcomes include changes in urine markers and kidney function.
Secondary outcomes focus on urine albumin/creatinine ratio, urine protein/creatinine ratio, and blood pressure.
Step 6
Completion of the study
The study is expected to conclude by July 31, 2025.
Final assessments are conducted to evaluate the effects of the treatment on kidney disease progression.

Who can join the trial?

7 criteria

Participant must be at least 18 years old at the time of signing the consent form.
Must have a clinical diagnosis of chronic kidney disease (CKD) with specific test results:
- eGFR (estimated glomerular filtration rate) between 25 and 60 mL/min/1.73m² at screening. This test measures how well the kidneys are filtering.
- UACR (urine albumin-to-creatinine ratio) of 300 mg/g or higher at screening. This test checks for protein in the urine, which can indicate kidney damage.
- Participants must be on a 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 first screening visit should be more than 110/65 mmHg and less than 150/90 mmHg. If blood pressure is higher than 150/90 mmHg, the screening phase can be extended to 4 weeks.
- Must be able to provide signed informed consent, which means they understand the study and agree to participate.
- Women who can have children must have a negative pregnancy test at the screening visit and use contraception during the study.

Who cannot join the trial?

10 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to the study medication are excluded.
Patients with uncontrolled high blood pressure are not eligible.
People with severe liver disease cannot take part in the study.
Individuals who have had a heart attack or stroke in the past six months are excluded.
Patients currently participating in another clinical trial are not eligible.
Individuals with a history of drug or alcohol abuse in the past year cannot participate.
Patients with a known history of certain types of cancer are excluded.
Individuals with a known infection that affects the immune system, like HIV, are not eligible.
Patients who have had a kidney transplant are excluded from the study.

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Odense University Hospital
Odense, Denmark

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Investigated drugs

Amiloride is a medication used in this clinical trial to help preserve kidney function in patients with chronic kidney disease. It is a type of diuretic, which means it helps the body get rid of excess salt and water. The study is investigating whether amiloride has additional benefits for the kidneys by blocking a specific protein called urokinase-type plasminogen activator (uPA). This protein might be involved in causing damage to the kidneys. The trial aims to see if amiloride can reduce kidney inflammation and protect against further kidney damage.

What is already known about the treatment

Amiloride – Amiloride is administered orally in tablet form. It is currently being studied for its potential benefits in treating chronic kidney disease (CKD). The main therapeutic indication is to preserve kidney function and reduce cardiovascular risks in CKD patients. At the molecular level, amiloride is believed to exert its effects by inhibiting the urokinase-type plasminogen activator, which may help protect the kidneys from damage. It is classified pharmacologically as a diuretic, commonly used to manage fluid retention and high blood pressure.

Investigated diseases

Chronic Kidney Disease – Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This disease progresses over time, often without noticeable symptoms in the early stages. As kidney function declines, waste products and fluid can build up in the body, leading to complications such as high blood pressure, anemia, and bone disease. The progression of chronic kidney disease can eventually lead to kidney failure, where the kidneys can no longer function effectively. This condition requires careful management to slow its progression and maintain kidney function for as long as possible.