Active not recruitingOBSERVATIONAL

Validation of a Proteomic Biomarker to Predict Progression of Chronic Kidney Disease

This research aims to find a new, better way to predict how chronic kidney disease (CKD) might progress. Doctors want to see if a special marker discovered in a blood or urine test can help them tell which patients are more likely to see their kidney function get worse within a year. This is important because identifying these patients earlier could mean they get extra support and treatment sooner, helping to slow down the disease. The study will compare this new marker to existing tests to see if it's more accurate. If successful, this could lead to improved monitoring and care for people living with CKD.

At a glance

Status

Active not recruiting

Sponsor

Angel Argiles

Enrolment target

213

Start

02 May 2023

Estimated completion

01 May 2026

Chronic Kidney Disease(CKD)Progression, Disease

What is this study about?

This study is all about finding a new way to predict how chronic kidney disease (CKD) might change over time. CKD means your kidneys aren't working as well as they should, and for some people, their kidney function can get worse quite quickly. Doctors are always looking for better tools to understand who might be at higher risk of this happening, so they can offer the right care at the right time.

Imagine a special 'marker' or signal in your blood or urine that could give doctors an early warning. That's what this study is exploring. Researchers are testing a new marker to see if it can accurately spot people whose kidney function is likely to decline significantly within about a year. They will compare this new marker with tests doctors already use to see if it's more effective or gives clearer information.

The main goal is to improve how we monitor and care for people with CKD. If this new marker works well, it could help doctors identify those who need closer attention or different treatments sooner, potentially slowing down the progression of their kidney disease. This could make a big difference in managing the condition and improving people's health.

Key takeaways

Researchers are seeking a new way to predict if kidney disease will worsen.
The study tests a special 'marker' in blood or urine.
This might help doctors identify patients at higher risk earlier.
Participation involves two visits over one year, with blood and urine tests.
The goal is to improve monitoring and care for people with kidney disease.

Who may be eligible?

To join this study, you need to be an adult between 18 and 85 years old and have chronic kidney disease (CKD). Your kidney function, measured by a test called eGFR, should be within a certain range (25-65 mL/min/1.73m2). You also need to have health insurance and be able to understand and communicate with the study team. Importantly, you'll need to give your written permission to take part.

There are also some reasons why you wouldn't be able to join. For example, if you've had a kidney transplant, currently have an acute kidney injury (a sudden worsening of kidney function), or are pregnant, you won't be eligible. The study also can't include people who the doctors feel have other health issues that might affect the study results, those who can't give proper consent, or people who may have issues with alcohol or drug abuse.

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 85 years old?
Do you have chronic kidney disease (CKD)?
Is your kidney function (eGFR) within the specified range (25-65)?
Are you able to communicate with the study team?
Have you NOT had a kidney transplant or a sudden kidney injury recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would have two study visits: one at the beginning and another about a year later. During these visits, the study team would check your health, including your kidney function, using standard checks like blood and urine tests. They would also collect extra samples of your blood and urine so they can look for the new special marker.

Sometimes, if these tests are already part of your usual care, you might also have other checks such as a 24-hour urine collection, an ultrasound scan of your kidneys, or even a kidney biopsy. You might also be asked to complete questionnaires or have interviews about social and ethical aspects related to kidney disease. The study will last for approximately one year, following your progress between the two main visits.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information found could help improve care for future patients with kidney disease. The main risks involve the usual discomfort of blood draws and providing urine samples. If you have a kidney biopsy as part of your routine care, there are standard risks associated with that procedure, which your doctor would explain fully. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Medizinische Universität Innsbruck
Verified postcode
Innsbruck, Austria
Néphrologie Dialyse St Guilhem
Verified postcode
Sète, France
Klinikum Bayreuth GmbH
Verified postcode
Bayreuth, Germany

Common questions

What is chronic kidney disease (CKD)?

CKD means your kidneys are damaged and can't filter blood as well as they should. This can lead to health problems over time.

What is a 'biomarker'?

A biomarker is like a signal in your body, often found in blood or urine, that can tell doctors something about your health or a disease.

Will taking part in this study change my current treatment?

No, this is an observational study, meaning it observes your health. It won't change the kidney disease treatment your doctor has already prescribed for you.

What defines 'CKD progression' in this study?

In this study, 'CKD progression' means a notable drop in your kidney function (eGFR) by at least 10% within one year.

How long will I be in the study?

You will participate in the study for about one year, with two main visits during that time.