RecruitingNAINTERVENTIONAL

A Methodological Study to Learn More About Kidney Function in Healthy People and in People With Reduced Kidney Function

Researchers want to check how reliable a new test is for measuring kidney function. This test looks at something called 'renal functional reserve' (RFR) and 'maximum glomerular filtration rate' (maxGFR), which are ways to understand how well your kidneys are working. By repeating this test twice over two months, they hope to find out if it's precise enough to be useful. If it is, this new test could help doctors better understand and track kidney problems in the future. The study will involve up to 50 adults, both healthy individuals and those with stable kidney issues, to gather information about their kidney health.

At a glance

Status

Recruiting

Phase

Sponsor

Bayer

Enrolment target

Start

06 Jan 2026

Estimated completion

19 Feb 2027

Acute Kidney Injury, Renal Insufficiency

What is this study about?

This study is designed to learn more about a special test that measures how well your kidneys are working. Imagine your kidneys have a reserve capacity, like a car's fuel tank that can hold extra fuel for a long journey. This test tries to measure that reserve, as well as the maximum amount of waste your kidneys can filter. It's important to know if this test gives consistent and accurate results because, if it does, it could become a really helpful tool for doctors to keep an eye on people's kidney health, especially for those with long-term kidney problems.

To do this, researchers will invite up to 50 adults to take part. Some of these people will have healthy kidneys, and others will have existing kidney problems that are stable and not getting worse quickly. By looking at both groups, the scientists can get a clearer picture of how the test works in different situations. This study doesn't involve any new medicines or treatments; it's purely about understanding more about a diagnostic test.

In simple terms, this research is a bit like checking the accuracy of a new ruler before you start building something. The 'new ruler' here is the kidney function test, and if it proves to be accurate, it could help doctors measure kidney health better, potentially leading to earlier detection and better management of kidney conditions in the future for many people.

Key takeaways

This study aims to improve kidney function tests.
It involves healthy people and those with stable kidney problems.
No new medicines are given; it's about diagnostic testing.
Participation includes a screening visit and three study days over 2-3 months.
You'll have blood and urine tests before and after a protein shake.
Your involvement helps advance future kidney care.

Who may be eligible?

You might be able to join this study if you are an adult between 18 and 75 years old.

It's important that your health has been stable, meaning no new medications or major changes to existing treatments for any long-term medical conditions in the last two months. Your weight should also be between 50 and 100 kg. If you are a woman, you must not be pregnant or breastfeeding.

You wouldn't be able to join if you've had surgery recently (in the last two months), have a newly diagnosed medical condition, or if your existing medical condition has significantly changed recently. You'd also be excluded if you have certain rare disorders (like issues with how your body processes amino acids), a severe allergy to milk products, severe liver disease, or if you regularly take certain painkillers called NSAIDs. People with very severe kidney problems (where your kidney function, measured by eGFR, is less than 30) are also not suitable for this study.

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 between 18 and 75 years old?
Has your health been stable, without new medicines or major health changes, in the last two months?
Do you weigh between 50 kg and 100 kg?
If female, are you not pregnant or breastfeeding?
Do you have any severe allergies to milk products?
Do you have severe liver disease or very severe kidney problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve a few visits and tests. First, you'll have a 'screening visit' to check if you're suitable for the study. After that, you'll come to the study centre on three separate days, with about a month between each visit.

On each of these three study days, you'll have some blood and urine samples taken. You'll also be asked to drink a protein shake. More blood and urine samples will then be taken after you've had the shake. These samples help the researchers measure different things in your blood and urine to see how your kidneys are functioning. They will also record some basic health information, such as your weight, blood pressure, and any medicines you are currently taking.

The entire study will last for about 2 to 2 and a half months for each person involved. There are no new medications or treatments to take as part of this study.

Potential risks and benefits

Participating in this study might not offer direct health benefits to you, but your contribution will be very valuable in helping researchers understand and potentially improve how we measure kidney function for future patients. Potential risks are generally low, mainly related to the blood tests (like slight bruising or discomfort at the injection site) and drinking the protein shake. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it won't affect any future medical care you receive.

Locations (1)

Bayer AG - Occupational Health Services
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is 'kidney function'?

Kidney function refers to how well your kidneys are working to filter waste products and excess water from your blood.

Will I have to take any new medicines?

No, this study does not involve taking any new medications or treatments. It's about testing how reliable a diagnostic test is.

How long will the study last for me?

For each person, the study will last for about 2 to 2 and a half months in total.

What does a 'protein shake' have to do with my kidneys?

The protein shake helps researchers see how your kidneys react and adjust to a challenge, which gives them clues about your kidney's 'reserve' capacity.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point, and your decision will not affect your medical care.

How to find out more

Bayer Clinical Trials Contact

clinical-trials-contact@bayer.com (+)1-888-84 22937 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.