Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Double-blind, placebo-controlled clinical trial to determine the effect of Patiromer on vascular function and its relationship with mineral metabolism parameters

This research study is investigating a medication called Patiromer, specifically looking at its effects on blood vessel health in individuals living with chronic kidney disease. The main goal is to understand if this drug can improve the flexibility and health of arteries. We will also be exploring how Patiromer interacts with key chemicals in the body, such as phosphate, calcium, and magnesium, which are important for bone health and other body functions. Participants will receive either the active drug or a placebo (a dummy treatment) to fairly assess the drug's impact. The study aims to gather important information that could help improve care for people with kidney disease.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacion Para La Investigacion Biomedica De Cordoba

Enrolment target

Start

24 Jul 2023

Chronic kindney disease

What is this study about?

This study is investigating a new treatment called Patiromer for people who have chronic kidney disease. Chronic kidney disease means your kidneys aren't working as well as they should, which can lead to various health problems over time. One area we're particularly interested in is how kidney disease affects your blood vessels, specifically making them stiff. Stiff blood vessels can increase the risk of heart problems.

The main purpose of this study is to see if Patiromer can help improve the health and flexibility of your blood vessels. We'll be measuring things like how quickly your pulse travels through your arteries and the pressure inside your arteries to see if there are any positive changes. We also want to understand if Patiromer affects important chemicals in your body, like phosphate and calcium, which are often out of balance in people with kidney disease and can impact blood vessel health.

By taking part in this study, you would be helping doctors and researchers understand more about chronic kidney disease and how new treatments might improve the health of blood vessels and overall well-being for patients in the future. This is a "Phase II" study, which means it's an early-stage study to explore the drug's effects and safety.

Key takeaways

Investigating a drug called Patiromer for chronic kidney disease.
Aims to improve blood vessel health, like artery flexibility.
Examines how the drug affects body chemicals (e.g., phosphate, calcium).
Uses a 'double-blind' approach (drug vs. placebo).
Requires regular visits for assessments, including blood and urine tests.

Who may be eligible?

To be considered for this study, you must be an adult, 18 years old or older. The study is open to both men and women.

You would need to have been diagnosed with chronic kidney disease. The study doctors will carefully check your medical history and conduct tests to make sure the study is suitable and safe for you.

There will be other specific health requirements and conditions that the study team will discuss with you. These are put in place to ensure your safety and that the study results are clear and accurate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have chronic kidney disease?
Are you comfortable taking a daily powdered medication?
Are you able to attend regular study appointments?
Are you willing to provide blood and urine samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a powder that you mix with water, apple juice, or cranberry juice and drink. This powder would either be the active study medication (Patiromer) or a placebo (a dummy powder that looks the same but contains no active drug). You wouldn't know which one you're taking, and neither would the study team, until after the study is complete.

Throughout the study, you would attend several appointments for assessments. These would include measurements of your blood pressure and pulse, and blood and urine samples would be taken. These samples help us check your kidney function and the levels of important minerals in your body.

We would also look at how well your blood vessel lining is working. The study duration and the exact number of visits would be explained in full detail by the study team before you agree to participate.

Potential risks and benefits

Taking part in a study like this may offer potential benefits, such as contributing to medical knowledge that could help future patients with kidney disease, and you would receive close medical monitoring throughout the study. However, there are also potential risks, including side effects from the study medication, discomfort from blood tests, or unforeseen reactions. The study team will explain all known potential risks in detail. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is chronic kidney disease?

Chronic kidney disease means your kidneys are damaged and don't filter your blood as well as they should over a long period. This can lead to health problems.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real drug but contains no active medicine. It helps us see if the drug is truly making a difference.

Why can't I know if I'm getting the real drug?

This is a 'double-blind' study, meaning neither you nor the study team knows whether you're getting the drug or placebo. This helps make the study results more reliable.

What will happen during the study visits?

You'll have your blood pressure checked, and blood and urine samples taken. These tests help us understand how your body is responding to the treatment.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.