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Study on Chronic Kidney Disease and Polycystic Kidney Disease Using Pyruvic Acid and MRI for Patients with These Conditions

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What is this trial about?

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

This clinical trial focuses on studying chronic kidney disease and autosomal dominant polycystic kidney disease, which are conditions affecting the kidneys. The study uses a special type of imaging called MRI (magnetic resonance imaging) to look at changes in the kidneys' metabolism. The treatment involves an injection of a substance called Hyperpolarized [1-13C]pyruvate, which helps make the MRI images clearer and more detailed.

The purpose of the study is to understand how these kidney diseases change the way the kidneys process energy. By using the MRI with the special pyruvate injection, researchers hope to see differences in how the kidneys of healthy people and those with kidney disease work. This includes looking at how the kidneys produce certain substances like lactate and alanine, which are related to energy use in the body. The study will include healthy volunteers as well as patients with chronic kidney disease and polycystic kidney disease.

Participants in the study will receive the pyruvate injection and then undergo an MRI scan. This will help researchers see the metabolic changes in the kidneys. The study aims to find out if these changes are linked to other signs of kidney damage, such as fibrosis (scarring) and inflammation, which are often seen in kidney disease. The information gathered from this study could help improve understanding of these diseases and lead to better ways to diagnose and treat them 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
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on age, medical condition, and other criteria. For women of childbearing age, a pregnancy test is conducted to ensure non-pregnancy.
A recent kidney biopsy is required for those with chronic kidney disease (CKD) to participate. This biopsy must have been performed within the last three months.
Step 2
MRI scan preparation
Preparation for the magnetic resonance imaging (MRI) scan involves understanding the procedure and its purpose. The scan aims to assess the metabolic changes in the kidneys using a special substance called hyperpolarized [1-13C]pyruvate.
The MRI scan is designed to detect changes in kidney metabolism, such as increased production of certain substances like lactate and alanine, which are associated with CKD.
Step 3
Administration of hyperpolarized pyruvate
The hyperpolarized [1-13C]pyruvate is administered through an injection into a vein. This is done to enhance the MRI images and provide detailed information about kidney metabolism.
The injection is given shortly before the MRI scan to ensure the substance is active during imaging.
Step 4
MRI scan
The MRI scan is conducted to capture images of the kidneys. This scan is non-invasive and uses magnetic fields to create detailed pictures of the kidney structure and function.
The scan helps identify metabolic changes and correlates these with measures of kidney health, such as fibrosis and inflammation.
Step 5
Post-scan assessments
After the MRI scan, additional assessments are performed. These include blood and urine tests to measure kidney function.
Expired carbon dioxide (CO2) levels may also be measured to provide further insights into metabolic processes.
Step 6
Follow-up visits
Follow-up visits are scheduled to monitor health and gather additional data. These visits help track any changes in kidney function over time.
The study is expected to continue until August 2028, with periodic assessments to ensure comprehensive data collection.

Who can join the trial?

6 criteria

Aged between 18 and 85 years old.
For women who have not yet gone through menopause, a test must confirm they are not pregnant.
For the group with **Polycystic Kidney Disease (PKD)**, participants must have **Autosomal Dominant Polycystic Kidney Disease**.
For the group with **Chronic Kidney Disease (CKD)**, participants must have CKD for any reason except PKD.
For the CKD group, participants must have had a recent **biopsy** (a small sample of tissue taken for testing) within 3 months of the MRI scan.
For PKD patients, the **eGFR** (a test that measures kidney function) must be greater than 60.

Who cannot join the trial?

10 criteria

Patients with any other serious medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of allergic reactions to substances similar to those used in the study.
Patients with severe liver disease.
Patients with a history of drug or alcohol abuse.
Patients who are unable to undergo MRI scans due to medical implants or other reasons.
Patients with uncontrolled high blood pressure.
Patients with a history of heart disease that is not stable.
Patients who are unable to give informed consent.

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Aarhus University Hospital
Aarhus, Denmark

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Investigated drugs

Hyperpolarized Pyruvate is a special form of a naturally occurring substance in the body called pyruvate. In this study, it is used in a special type of MRI scan to help doctors see how the kidneys are working. By using hyperpolarized pyruvate, the MRI can show changes in the way the kidneys process energy, which is important for understanding conditions like chronic kidney disease (CKD) and polycystic kidney disease (PKD). This helps doctors see if the kidneys are using energy differently than they should, which can be a sign of disease.

Pyruvic Acid

What is already known about the treatment

Hyperpolarized Pyruvate – This medication is administered through an injection and is used in conjunction with MRI scans to help visualize metabolic changes in the kidneys. It is currently being studied in clinical trials to better understand its role in imaging metabolic changes in chronic kidney disease (CKD) and autosomal dominant polycystic kidney disease (ADPKD). The main therapeutic indication is to detect metabolic shifts in kidney diseases, which can help in assessing the severity and progression of these conditions. At the molecular level, hyperpolarized pyruvate enhances MRI signals, allowing for the detection of increased glycolysis and other metabolic changes in diseased kidneys. It is classified as a diagnostic agent in pharmacology, specifically used to improve imaging techniques.

Investigated diseases

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
This genetic disorder is characterized by the growth of numerous cysts in the kidneys. These cysts are fluid-filled sacs that can enlarge the kidneys and disrupt their normal function. Over time, the increasing number of cysts can lead to a decline in kidney function. The disease progresses as the cysts grow larger and more numerous, potentially causing pain and other complications. The kidneys may become significantly enlarged, and the cysts can also affect other organs. The progression of the disease varies among individuals, with some experiencing more rapid changes than others.
Chronic Kidney Disease (CKD)
This condition involves the gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood. As the disease progresses, waste products can build up in the body, leading to various health issues. CKD can result from a variety of causes, including diabetes and high blood pressure. The progression of the disease can lead to complications such as high blood pressure, anemia, and bone disease. The rate of progression can vary, with some individuals experiencing a slow decline in kidney function.