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Study to Compare Non-Radioactive Methods for Measuring Kidney Function in Patients with Chronic Kidney Disease Using Sodium Iotalamate, Sodium Iodohippurate, and Iohexol

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What is this trial about?

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

This clinical trial is focused on studying Chronic Kidney Disease and Kidney Failure. The study will use different substances to measure how well the kidneys are working. These substances include Sodium Iotalamate (125I), Sodium Iodohippurate (131I), and Iohexol. Additionally, Epinephrine and Clemastine are involved in the study. The purpose of the study is to determine if the kidney function measurement using Sodium Iotalamate (125I) and Sodium Iodohippurate (131I) is equivalent to the measurement using Iohexol.

Participants in the study will receive these substances through an injection into a vein. The study will compare the results from these different substances to see if they provide similar information about kidney function. The study will involve a single treatment period, and participants will be monitored to ensure their safety throughout the process.

By comparing these methods, the study aims to find the best way to measure kidney function without using radioactive substances. This could help improve the care and treatment of people with kidney problems in the future. Participants will be randomly assigned to receive either the study substances or a placebo, and their kidney function will be measured and compared.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing written informed consent.

    Eligibility requires being scheduled for a kidney function test as part of standard care and being 18 years or older.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm eligibility and gather baseline health information.

  3. Step 3

    Administration of sodium iotalamate (125i)

    Sodium iotalamate (125i) is administered through an intravenous bolus injection or IV infusion.

    This step is part of the process to measure the glomerular filtration rate (GFR).

  4. Step 4

    Administration of iohexol

    Iohexol is administered through an intravenous bolus injection or IV infusion.

    This step is also part of the process to measure GFR.

  5. Step 5

    Administration of epinephrine

    Epinephrine is administered through an intravenous slow bolus injection.

    This medication is used to manage potential allergic reactions during the trial.

  6. Step 6

    Administration of clemastine

    Clemastine is administered through intravenous, subcutaneous, or intramuscular injection.

    This medication is used to prevent or treat allergic reactions.

  7. Step 7

    Monitoring and follow-up

    Regular monitoring is conducted to assess the body's response to the medications and to measure GFR.

    Follow-up visits are scheduled to ensure safety and gather data for the study.

  8. Step 8

    Completion of the study

    The study is estimated to end by July 1, 2025.

    Final assessments are conducted to conclude participation and gather final data.

Who can join the trial?

3 criteria

  • Must be scheduled to have a kidney function measurement test as part of their regular medical care.
  • Must be **18 years old or older**.
  • Must provide **written informed consent**, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

5 criteria

  • Patients with **Chronic Kidney Disease** or **Kidney Failure** cannot participate. These are conditions where the kidneys do not work as well as they should.
  • Patients who are not within the specified age range for the study cannot participate. The study is only for certain age groups.
  • Patients who do not belong to the specific clinical trial group required for the study cannot participate. This means the study is looking for people with certain characteristics or conditions.
  • Both **male** and **female** patients are eligible, but if a patient does not identify as either, they may not be able to participate.
  • Patients who are considered part of a **vulnerable population** cannot participate. This usually means people who might need extra protection or care.
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Investigated drugs

  • 125I-iothalamate

    is a medication used in this trial to measure kidney function. It is a radioactive substance that helps doctors understand how well the kidneys are filtering waste from the blood.

  • 131I-hippuran

    is another radioactive medication used in the trial to assess kidney function. It works similarly to 125I-iothalamate by providing information on the efficiency of the kidneys in filtering blood.

  • Iohexol

    is a non-radioactive contrast agent used in this study to measure kidney function. It is used as an alternative to the radioactive substances to see if it can provide the same information about how well the kidneys are working.

What is already known about the treatment

Iohexol – Iohexol is administered intravenously and is used primarily in diagnostic imaging to measure kidney function. It is currently being evaluated in clinical trials for its effectiveness in determining glomerular filtration rate (GFR) without the use of radioactive substances. The main therapeutic indication for iohexol is in assessing kidney health, particularly in conditions like chronic kidney disease and kidney failure. At the molecular level, iohexol works by being filtered through the kidneys, allowing for the assessment of kidney filtration efficiency. It is classified as a non-ionic, water-soluble contrast agent.

Investigated diseases

  • Chronic Kidney Disease

    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, which can lead to a buildup of harmful substances in the body. As the disease progresses, individuals may experience symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. The progression can vary, with some people experiencing a slow decline in kidney function, while others may see a more rapid deterioration. It is often associated with other health issues like high blood pressure and diabetes. Regular monitoring and lifestyle adjustments are crucial to managing the condition.

  • Kidney Failure

    Also known as renal failure, this condition occurs when the kidneys lose their ability to filter waste and balance fluids effectively. It can develop suddenly, known as acute kidney failure, or gradually, referred to as chronic kidney failure. Symptoms may include reduced urine output, fluid retention, and fatigue. As kidney function declines, waste products and excess fluids can accumulate in the body, leading to serious health issues. The progression of kidney failure can lead to the need for dialysis or a kidney transplant. Managing underlying conditions and regular medical check-ups are important to slow the progression.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509156-34-02Estimated enrolment200 patientsSponsorUniversitair Medisch Centrum Groningen

sourced from the EU Clinical Trials Register and site verification

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