Study on the Effects of Amiloride and Sodium Chloride on Vascular Stiffness in Patients with Polycystic Kidney Disease

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What is this study about?

This clinical trial is focused on studying Autosomal Dominant Polycystic Kidney Disease (ADPKD), a genetic condition that affects the kidneys and can lead to the development of numerous cysts. The study aims to explore whether a high-salt diet worsens arterial stiffness in patients with ADPKD and if treatment with amiloride, a medication that helps the body get rid of excess salt and water, can prevent these effects. The trial will also investigate if amiloride can further reduce arterial stiffness when patients follow a low-salt diet.

Participants in the study will be divided into groups to receive different treatments. Some will receive a salt supplement, while others will receive a placebo, which is a substance with no active medication. The study will also involve the use of sodium chloride and potato starch as part of the treatment regimen. The trial will last for a period of up to four weeks, during which participants will take the treatments orally, in the form of tablets or capsules.

The main goal of the study is to observe changes in arterial stiffness, which is a measure of how flexible or stiff the arteries are, in response to the treatments. Additional observations will include blood pressure measurements over 24 hours, and blood tests to check for signs of inflammation and other related markers. Some participants may also undergo MRI scans to measure sodium levels in the body. This research will help to understand the impact of salt intake and amiloride treatment on arterial health in individuals with ADPKD.

1 joining the study

Upon joining the study, participation is confirmed through informed consent. This involves understanding the study’s purpose and agreeing to take part.

2 initial assessment

An initial assessment is conducted to evaluate health status. This includes measuring kidney function and ensuring eligibility based on specific criteria.

3 randomization

Participants are randomly assigned to one of two groups: a high-salt diet group or a placebo group. This helps in comparing the effects of different treatments.

4 dietary phase

Participants follow a specific diet based on their group assignment. The high-salt group consumes a diet with increased salt, while the placebo group follows a standard diet.

5 medication phase

Participants receive amiloride, a medication taken orally. The dosage and frequency are determined by the study protocol. This phase aims to assess the medication’s effect on arterial stiffness.

6 monitoring and assessments

Regular monitoring includes measuring pulse wave velocity, blood pressure, and serum markers. These assessments help track changes in arterial stiffness and other health indicators.

7 MRI scans

Some participants undergo 23Na-MRI scans to measure sodium accumulation in tissues. This provides additional data on the body’s response to dietary salt.

8 final evaluation

At the end of the study, a final evaluation is conducted. This includes reviewing all collected data to determine the effects of the treatments on arterial stiffness.

Who Can Join the Study?

You must be an adult diagnosed with Autosomal Dominant Polycystic Kidney Disease (ADPKD). This is a condition where cysts form in the kidneys, and it is inherited from one of your parents.
Your diagnosis should be based on the Ravine criteria or you should have a documented mutation in the Pkd 1 or 2 genes. These are specific ways to confirm the presence of ADPKD.
Your kidney function, measured by a test called CKD-EPI eGFR, should be at least 60 ml/min/1.73m². This test checks how well your kidneys are filtering blood.
You must be able to understand the study and agree to participate by signing a form, which is known as providing informed consent.
Both men and women can participate in the study.

Who Cannot Join the Study?

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to the study medication are excluded.
People with uncontrolled high blood pressure, which means their blood pressure is not well-managed, are not eligible.
Participants with significant heart problems, such as heart failure, are not allowed to join.
Those with severe liver disease, which affects how the liver functions, cannot take part.
Individuals with kidney problems other than Autosomal Dominant Polycystic Kidney Disease are excluded.
Patients who are currently participating in another clinical trial are not eligible.
People with a history of drug or alcohol abuse, which means using substances in a harmful way, are not allowed to participate.
Individuals who have had a major surgery within the last three months are excluded.
Participants with any other medical condition that the study doctors believe would make it unsafe for them to participate are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Enufqgv Umgsdyfrbfun Marurux Cwaiycf Rvybpcgkv (mpzbjnr Mmw	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	05.05.2022

Trial locations

Investigated drugs:

Amiloride is a medication used in this trial to see if it can help reduce the stiffness of blood vessels in patients with autosomal dominant polycystic kidney disease (ADPKD). The study is looking at whether amiloride can counteract the effects of a high-salt diet on blood vessel stiffness and if it can further reduce stiffness when patients follow a low-salt diet.

Investigated diseases:

Congenital cystic kidney disease

Autosomal Dominant Polycystic Kidney Disease – This is a genetic disorder characterized by the growth of numerous cysts in the kidneys. These cysts are filled with fluid and can lead to an increase in kidney size and a decrease in kidney function over time. The disease often progresses with the development of high blood pressure and can cause pain in the back or sides. As the cysts grow, they can also lead to complications such as kidney stones or infections. The progression of the disease varies among individuals, with some experiencing more rapid kidney function decline than others.

Trial ID:

2024-512544-27-00

NCT ID:

NCT05228574

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Amiloride and Sodium Chloride on Vascular Stiffness in Patients with Polycystic Kidney Disease

What is this study about?

Who Can Join the Study?

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